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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer

    Protocol: OSU-11151

    Eligibility:

    Inclusion Criteria:

    • Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable; the histology must be clear cell carcinoma or predominant clear cell carcinoma
    • Patients may have received up to two prior therapies including VEGF, mTOR and PD-1/PDL1 inhibitors; prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
    • Patients must have measurable or evaluable disease
    • Eastern Cooperative Oncology Group (ECOG) performance status 0
    • Life expectancy of greater than 6 months
    • Hemoglobin >= 12 g/dL
    • Leukocytes >= 3,000/mm^3
    • Absolute neutrophil count >= 1,500/mm^3
    • Platelets >= 100,000/mm^3
    • Total bilirubin =< 1.5 x laboratory upper limit of normal
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal
    • Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 ml/min
    • Lactate dehydrogenase (LDH) within normal limits (WNL)
    • Corrected calcium =< 10 mg/dL
    • Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
    • Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
    • Forced expiratory volume (FEV) 1 >= 2.0 liters or >= 75% of predicted for height and age; (pulmonary function tests [PFTs] are required for patients over 50 or with significant pulmonary or smoking history)
    • No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina; patients who are over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia
    • No history of cerebrovascular accident or transient ischemic attacks
    • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men with female partners of child bearing potential must also agree to use adequate contraception
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • Patients who have received more than two prior therapies
    • Concurrent use of valproic acid is not allowed
    • Patients may not be receiving any other investigational agents
    • Patients with untreated central nervous system (CNS) metastases; patients should have a head CT/magnetic resonance imaging (MRI) within 28 days prior to treatment initiation; patients with previously excised/gamma knifed solitary or oligometastases and controlled disease are eligible
    • Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (< the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months, hypertension (defined as blood pressure of > 160 mmHg systolic and/or > 90 mmHg diastolic on medication) history of peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements
    • Patients with a history of allergy to entinostat or other medications that have a benzamide structure (i.e. tiapride, remoxipride, and clebopride)
    • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with entinostat
    • Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
    • Serious or non-healing wound, ulcer or bone fracture
    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 therapy
    • Anticipation of need for major surgical procedures during the course of the study
    • Left ventricular ejection function < 45%
    Learn More
  • open for enrollment

    Study of BKM120 &amp; Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma

    Protocol: OSU-13027

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically confirmed indolent B-cell NHL or mantle cell lymphoma; acceptable subtypes of indolent B-cell NHL include follicular lymphoma (grades 1, 2, or 3a), marginal zone lymphoma, or lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia; patients with mantle cell lymphoma must have a documented t(11;14) or overexpression of cyclin D1 by immunohistochemical evaluation; patients with active large cell transformation are not eligible; however, patients with a history of large cell transformation are eligible provided that there is no current clinical evidence of active transformed lymphoma
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • At least one prior therapy; prior autologous or allogeneic stem cell transplant is allowed; patients may not be on chronic immunosuppressive therapy for graft-versus-host disease (GVHD); patients who have received prior treatment with a pan-selective PI3K inhibitor are not eligible; however, prior therapy with a selective PI3K inhibitor, Bruton's tyrosine kinase inhibitor, or other B-cell receptor targeting agents is allowed
    • Serum creatinine =< 2.0 mg/dL
    • Total bilirubin =< upper limit of normal
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limit of normal
    • Absolute neutrophil count (ANC) >= 750/mm^3
    • Platelets >= 50,000/ mm^3
    • Serum lipase =< upper limit of normal
    • Serum amylase =< upper limit of normal
    • International normalized ratio (INR) =< 2.0
    • Fasting glucose < 120mg/dL
    • Recovery to =< grade 1 toxicities associated with prior therapy
    • Negative serum pregnancy test; if, on cycle 1 day 1, greater than 72 hours has elapsed since the last negative result, a serum pregnancy test must be repeated and be negative on cycle 1 day 1 (C1D1) for the patient to remain eligible
    • Patient has the ability and willingness to provide informed consent and has signed the informed consent document

    Exclusion Criteria:

    • Pregnant or breast-feeding women and women of childbearing age or men who are unwilling to use adequate contraception; females of childbearing age and potential (i.e., not surgically sterilized) must use a second form of contraception, including total abstinence, intra-uterine device, double-barrier contraception, or other non-hormonal form of contraception
    • Patients with a history of central nervous system involvement by lymphoma
    • The presence of co-existing medical conditions that would limit compliance with study medications, including, but not limited to active infection, active or untreated cardiac or pulmonary disease, or malignancy
    • Patients with significant, symptomatic deterioration of lung function confirmed by spirometry, diffusion capacity of carbon monoxide (DLCO), or resting oxygen (O2) saturation
    • Patients with impairment of gastrointestinal function that may alter the absorption of BKM120
    • Patients currently being actively treated or who have been treated within the past 3 years for an unrelated malignancy (except non-melanoma skin cancer, cervical carcinoma in-situ, and low risk prostate cancer)
    • Patients who have undergone major surgery within 2 weeks prior to study enrollment or who have not recovered from a major surgery
    • Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active or carriers)
    • Patients with a fasting blood glucose >= 120 mg/dL (6.7mmol/L); patients with diabetes mellitus are eligible if they require oral agents only and have a fasting blood glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily long-acting or mealtime insulin are not eligible; patients who have previously required treatment for hyperglycemia due to steroids or other medications are eligible as long as they have not required insulin or any other oral agent within 2 months prior to study enrollment
    • Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is >= 10mg prednisone
    • Patients with a known hypersensitivity to BKM120 or its excipients
    • Patients with active moderate or severe major mood or psychiatric disorder as judged by the investigator, primary care physician, counselor, psychiatrist, or as a result of the patient's mood assessment questionnaire that may interfere with the ability to comply with the trial; in addition, given the prior mood-associated toxicities, patients with a history of psychiatric hospitalization within the past 5 years, electroconvulsive therapy (ECT) within the past 5 years, or whose psychiatric condition has been unstable within 2 months prior to study enrollment requiring addition or change of psychotropic medications are not eligible; examples include, but are not limited to:
    • Medically documented history of or active major depressive episode requiring inpatient or intensive outpatient therapy, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or active ideation, or homicidal ideation (immediate risk of doing harm to others); patients under the care of a primary care physician who are treated with one oral agent and who have not required dose adjustments or new medications within 2 months prior to study enrollment and who otherwise meet eligibility requirements may be enrolled
    • >= Common Terminology for Adverse Events (CTCAE) version 4.0 grade 3 anxiety
    • Patients meeting the cutoff score of >= 12 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder-7 (GAD-7) mood scale, respectively, or who select a positive response of "1, 2, or 3" to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) are not eligible
    • Patients with diarrhea >= CTCAE grade 2
    • Patients with active cardiac disease including any of the following:
    • Left ventricular ejection fraction < 50% as determined by multi gated acquisition scan (MUGA) scan or echocardiogram
    • Corrected QT interval (QTc) > 480 msec on screening ECG (using the QTcF formula)
    • Active angina pectoris
    • Ventricular arrhythmias except for benign premature ventricular contractions
    • Supraventricular or nodal arrhythmias or any conduction abnormality requiring a pacemaker or automatic implantable cardioverter defibrillator (AICD)
    • Valvular disease with documented compromise in cardiac function
    • Symptomatic pericarditis
    • Myocardial infarction within the past 6 months
    • Congestive heart failure (New York Heart Association [NYHA] functional classification III-IV)
    • Patients who are currently receiving treatment with medications with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to study enrollment
    • Patients who have taken herbal medications and certain fruits within 7 days prior to study enrollment are not eligible; herbal medications include, but are not limited to, St John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; exclusionary fruits include the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
    • Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to study enrollment; (please note that co-treatment with weak inhibitors of CYP3A is allowed)
    • Patients who have received oral or IV chemotherapy, targeted anticancer therapy or radiation therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to study enrollment
    • Patients who are currently taking therapeutic doses of warfarin sodium or any other Coumadin-derivative anticoagulant; patients who can be safely changed to enoxaparin or other non-warfarin derived anti-coagulant and who otherwise meet eligibility requirements may be enrolled
    Learn More
  • open for enrollment

    A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

    Protocol: OSU-12169

    Eligibility:

    Inclusion Criteria:

    • Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
    • Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
    • Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)

    Exclusion Criteria:

    • Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
    • Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
    • Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

    Principal Investigator: Gregory A Otterson, MD

    Learn More
  • open for enrollment

    Pioglitazone in Follicular or Follicular Variant of Papillary Thyroid Cancers

    Protocol: OSU-13070

    Eligibility:

    Inclusion Criteria:

    1. Patients must have histologically confirmed follicular thyroid carcinoma or follicular variant of papillary thyroid carcinoma, with the PAX8-PPARgamma translocation (translocation testing will be performed on archived tissue during the screening period).

    Refractory to radioactive iodine (RAI) as defined by: the tumor does not concentrate RAI; or the patient has had RAI within the last 16 months and has had progression despite that RAI; or the last RAI treatment was >16 months ago and the patient progressed after at least two RAI treatments; or the patient has received RAI treatments with a cumulative RAI dose of =22.2 GBq (600 mCi)

    Not a candidate for surgery or RAI therapy with curative intent.

    Lesions that would be treated by external beam radiation therapy (EBRT) based on standard of care can be so treated, but then cannot be used as target lesions.

    2. Measurable disease by RECIST 1.1 criteria.

    3. Documented disease progression by RECIST 1.1 in the past 14 months.

    4. Availability of histological material (primary tumor or metastases) for review of the diagnosis and demonstration of PAX8-PPARgamma fusion gene.

    5. Adequate TSH suppression (<0.5 mIU/L)

    6. Prior chemotherapy or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolved.

    7. Prior radioactive iodine must have been completed at least 6 months prior to registration, or there must be documented disease progression since such therapy if it was within 6 months. Sites that have received EBRT must have disease progression post-EBRT to be used as sites of measurable disease.

    8. Age 18 - 75 years of age

    9. Life expectancy of greater than 6 months.

    10. ECOG performance status 2 or less.

    11. Patients must have normal organ function as defined below:

    AST(SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal (within 1 month of study Day 1)

    12. Patients must be able to consume oral medications.

    13. Women of childbearing potential must have a negative pregnancy test at baseline prior to receiving any study drug and must practice effective contraception while on study. (Pregnant or lactating patients are excluded).

    14. All patients must sign an informed consent prior to enrollment.

    Exclusion Criteria:

    1. Patients may not be receiving any other investigational agents.

    2. Patients with known untreated brain metastases.

    3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pioglitazone.

    4. Diagnosis of diabetes mellitus or current therapy with any drugs used to treat diabetes mellitus, including but not limited to insulin, sulfonylureas, metformin, rosiglitazone (Avandia), and pioglitazone (Actos) within 14 days of study Day 1

    5. Therapy with rosiglitazone (Avandia) or pioglitazone (Actos) at any time since the diagnosis of thyroid cancer.

    6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, or cardiac arrhythmias.

    7. Pregnant women are excluded from this study because pioglitazone is a U.S. Food and Drug Administration Pregnancy Category C drug. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pioglitazone, breastfeeding should be discontinued if the mother is treated with pioglitazone.

    8. No concurrent radiotherapy or chemotherapy may be given to the patient during the administration of the study drug.

    9. Patients with uncontrolled malabsorption syndromes.

    10. Patients with a history of congestive heart failure of any New York Heart Association class.

    11. Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen.

    12. Use of rifampin (strong CYP2C8 inducer) within 14 days of study Day 1.

    13. Other current malignancy than the disease under study.

    14. Grade 2 or worse edema within 14 days of study Day 1, per CTCAE v4.

    Principal Investigator: Manisha H. Shah, MD

    Learn More
  • open for enrollment

    Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

    Protocol: GOG-9923

    Eligibility:

    Inclusion Criteria:

    • Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, or carcinosarcoma stage II, III, or IV with either optimal (=< 1 cm residual disease) or suboptimal residual disease
    • All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, or carcinosarcoma with appropriate tissue for histologic evaluation
    • Patients with the following histologic cell types are eligible:
    • Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma not otherwise specified (N.O.S.) or carcinosarcoma
    • Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to CTEP Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
    • Platelets greater than or equal to 100,000/mm^3
    • Regimens I and II: Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
    • Regimen III: Creatinine no greater than the institutional upper limits of normal
    • Bilirubin less than or equal to 1.5 x ULN (CTEP CTCAE version 4.0, grade 1)
    • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN (CTEP CTCAE version 4.0, grade 1)
    • Alkaline phosphatase less than or equal to 2.5 x ULN (CTEP CTCAE version 4.0, grade 1)
    • Albumin greater than or equal to 3.0 g/dL
    • Neuropathy (sensory and motor) less than or equal to CTEP CTCAE version 4.0, grade 1
    • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 x ULN
    • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
    • Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction
    • Patients who have met the pre-entry requirements specified
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information

    Exclusion Criteria:

    • Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB low-grade epithelial ovarian or fallopian tube cancers) are not eligible
    • NOTE: Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
    • Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
    • Stage not greater than IB
    • No more than superficial myometrial invasion
    • No vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
    • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
    • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
    • Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last five years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
    • Patients with acute hepatitis or active infection that requires parenteral antibiotics
    • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
    • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
    • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures or history of seizures, and/or any CNS metastases are ineligible
    • Patients with history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study are ineligible
    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
    • Myocardial infarction or unstable angina < 6 months prior to registration
    • New York Heart Association (NYHA) class II or higher congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • CTEP CTCAE version 4.0, grade 2 or higher peripheral ischemia (brief [< 24 hrs] episode of ischemia managed non-surgically and without permanent deficit)
    • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
    • Patients with clinically significant proteinuria (urine protein creatinine ratio greater or equal to 1.0)
    • Patients with invasive procedures or anticipation of invasive procedures within the following timeframes as defined below:
    • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
    • Major surgical procedure anticipated during the course of the study
    • Core biopsy within 7 days prior to the first date of bevacizumab therapy (cycle 2)
    • Patients who are pregnant or nursing
    • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration or nutrition
    • Patients with GOG performance status of 3 or 4

    Principal Investigator: David M O'Malley, MD

    Learn More
  • open for enrollment

    BI 836858 Dose Escalation in Refractory or Relapsed Acute Myeloid Leukemia

    Protocol: OSU-12006

    Eligibility:

    Inclusion criteria:

    1. Diagnosis of relapsed or refractory AML with at least one prior treatment for acute myeloid leukemia.

    2. Expression of CD33 on more than 30% of bone marrow blasts.

    3. Eastern Cooperative Oncology Group Performance Status 0, 1 or 2

    4. Age 18 years or older

    5. Written informed consent which is consistent with International Conference on Harmonization ¿ Good Clinical Practice (ICH-GCP) guidelines and local legislation.

    Exclusion criteria:

    1. Patients with acute promyelocytic leukemia according to WHO definition.

    2. Patients with > 5.000 leukocytes/µl in the peripheral blood

    3. Anti-leukemia therapy within two weeks before first treatment with BI 836858, 4 weeks for biologics

    4. Allogeneic stem cell transplantation within the last 3 months or with evidence of graft versus host disease

    5. Patients who are candidates for allogeneic stem cell transplantation.

    6. Second malignancy currently requiring active therapy.

    7. Symptomatic central nervous system involvement

    8. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN), or AST or ALT greater than 5 times the ULN for those with Gilbert syndrome.

    9. Prothrombin time (PT) >1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)

    10. Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.

    11. Serum creatinine greater than 2.0 mg/dl

    12. Known human immunodeficiency virus (HIV) infection or active hepatitis B virus or hepatitis C virus infection.

    13. Concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia

    14. Psychiatric illness or social situation that would limit compliance with trial requirements

    15. Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug

    16. Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of BI 836858

    17. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for 6 months after the last administration of BI 836858

    18. Pregnant or nursing female patients

    19. Treatment with another investigational agent under the following conditions:

    1. Within two weeks (4 weeks for biologics) of first administration of BI 836858; or

    2. Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator.

    3. Concomitant treatment with another investigational agent while participating in this trial.

    20. Prior treatment with a CD33 antibody

    21. Patient unable or unwilling to comply with the protocol.

    Principal Investigator: William G Blum, MD

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  • open for enrollment

    IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

    Protocol: OSU-11179

    Eligibility:

    Inclusion Criteria:

    • Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL).
    • Adequate organ function
    • ECOG = 2
    • Recovered or stabilized from prior treatments.

    Exclusion Criteria:

    • Allogeneic stem cell transplantation
    • Pregnant or lactating females
    • Known central nervous system, meningeal or epidural disease including brain metastases
    Learn More
  • open for enrollment

    Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma

    Protocol: OSU-13244

    Eligibility:

    Inclusion Criteria:

    • Provided signed written informed consent
    • Males and females >=18 years of age (at the time consent is obtained).
    • Histologically or cytologically confirmed diagnosis of small cell lung carcinoma. Subjects must have measurable disease per RECIST 1.1 (for Part 2 only).
    • Recurrent or refractory disease after receiving at least one prior standard/approved platinum-containing chemotherapy regimen, or where standard therapy is refused. Part 2 only: Subjects must have recurrent disease after receiving a maximum of two prior chemotherapy regimens including at least one platinum containing regimen.
    • Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. (ECOG performance status of 0 or 1).
    • Tumor tissue requirements: Availability of archival tissue, or willingness to undergo fresh biopsy at baseline; Enrollment in PK/PD cohort may be limited to subjects with disease amenable to pre- and post-dose biopsies, and willingness to undergo biopsy.
    • All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia)
    • Adequate baseline organ function
    • Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, as defined in protocol, during the study and for 7 days following the last dose of study treatment.
    • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in protocol from the administration of the first dose of study treatment until 3 months after the last dose of study treatment to allow for clearance of any altered sperm.
    • Able to swallow and retain orally administered study treatment and does not have any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
    • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

    Exclusion Criteria:

    • Concurrent malignancy other than SCLC. History of other malignancy is allowed as long as there is no evidence of active disease or need for treatment.
    • Currently receiving anti-cancer therapy. Exceptions: Zoledronic acid and denosumab to treat bone metastasis are allowed.
    • Received major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK2879552 administration. Chemotherapy regimens with delayed toxicity within the last four weeks (six weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity or palliative radiation to a limited area within the last two weeks.
    • Administration of an investigational drug within 28 days or 5 half-lives, whichever is shorter preceding the first dose of study treatment(s) in this study.
    • French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous 28 days.
    • Subjects with current/a history of bleeding disorder or coagulopathy or who are at particularly high risk for bleeding complications.
    • Requiring anticoagulants at therapeutic doses or platelet inhibitor.
    • Current use of a prohibited medication or expected to require any of these medications during treatment with the investigational drug
    • Evidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
    • Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infections. Subjects with laboratory evidence of HBV clearance may be enrolled
    • Leptomeningeal metastases or spinal cord compression due to disease.
    • Subjects with previously untreated or uncontrolled brain metastases.
    • Cardiac abnormalities
    • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2879552 or LSD1 inhibitors that contraindicates their participation.
    • Lactating female
    • Consumption of Seville oranges, grapefruit, grapefruit hybrids, grapefruit juice, pommelos, or exotic citrus fruits, from 1 day prior to the first dose of study treatment(s) until the last dose of study drug.
    Learn More
  • open for enrollment

    Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery

    Protocol: OSU-13124

    Eligibility:

    Inclusion Criteria:

    • Written informed consent in accordance with federal, local, and institutional guidelines
    • Patients with unresectable melanoma
    • Patients must have received at least one prior systemic anticancer regimen (chemotherapy, biologic therapy, or targeted therapy) for metastatic disease
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Total white blood cell (WBC) count >= 3000/mm^3
    • Absolute neutrophil count (ANC) >= 1500/mm^3
    • Platelet count >= 100,000/mm^3
    • Bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 times ULN)
    • Alanine aminotransferase (ALT) < 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT < 5.0 times ULN is acceptable
    • Estimated creatinine clearance of >= 50 mL/min, calculated using the formula of Cockroft and Gault
    • Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose

    Exclusion Criteria:

    • Patients who are pregnant or lactating
    • Radiation, chemotherapy, immunotherapy or any other systemic anticancer therapy =< 3 weeks prior to initiation of therapy
    • Major surgery within four weeks before initiation of therapy
    • Unstable cardiovascular function:
    • Symptomatic ischemia, or
    • Uncontrolled clinically significant conduction abnormalities (e.g.: ventricular tachycardia on antiarrhythmics are excluded and 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block [LAFB]/right bundle branch block [RBBB] will not be excluded)
    • Congestive heart failure (CHF) of New York Heart Association (NYHA) class >= 3, or
    • Myocardial infarction (MI) within 3 months of initiation of therapy
    • Uncontrolled active infection within one week prior to first dose
    • Known to be human immunodeficiency virus (HIV) seropositive
    • Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus [HBV] surface antigen)
    • Patients with active central nervous system (CNS) malignancy
    • Asymptomatic small lesions are not considered active
    • Treated lesions may be considered inactive if they are stable for at least 3 months
    • Patients will be excluded if they have had a major resection of the bowel that could influence absorption, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation within 28 days prior to beginning study treatment
    • Grade >= 2 peripheral neuropathy within 14 days prior to initiation of therapy
    • History of seizures, movement disorders or cerebrovascular accident within the past 5 years
    • Patients with known macular degeneration or uncontrolled glaucoma
    • In the opinion of the investigator, patients who are significantly below their ideal body weight
    • Serious psychiatric or medical conditions that could interfere with treatment
    • Participation in an investigational anti-cancer study within 3 weeks prior to initiation of therapy
    • Concurrent therapy with approved or investigational anticancer therapeutic
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  • open for enrollment

    An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy

    Protocol: OSU-13211

    Eligibility:

    Inclusion Criteria:

    Disease status

    • Parts A and B: Histologically confirmed advanced solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom regimens containing gemcitabine, cisplatin, and/or etoposide might be considered, and with measurable disease according to RECIST criteria
    • Part C1:
    • Advanced (Stage IIIB or IV, not eligible for resection or definitive radiotherapy), histologically confirmed squamous non-small cell lung cancer (NSCLC) and who have not previously received chemotherapy for metastatic disease.
    • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample
    • Measurable disease according to RECIST criteria
    • Part C2:
    • Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) negative breast cancer.
    • Received a prior taxane-based regimen and no more than 1 additional regimen in the metastatic setting
    • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample d. Measurable disease according to RECIST criteria
    • Part C3:
    • Histologically confirmed SCLC that has relapsed from, or was refractory to, prior chemotherapy. Refractory disease is defined as relapse within 90 days of completing chemotherapy, or lack of tumor response while on therapy.
    • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample
    • Measurable disease according to RECIST criteria
    • Hematological and biochemical indices within protocol specified ranges at screening.

    Exclusion Criteria:

    • Radiotherapy (except for palliative reasons) endocrine therapy, immunotherapy, or chemotherapy during the previous 4 weeks
    • Parts A and B:
    • Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.

    (a) History of prior dose reductions or dose interruptions while receiving cisplatin or carboplatin due to toxicity from the platinum or intolerance to either agent.

    • More than 2 prior distinct chemotherapy regimens used for treatment of advanced stage disease containing DNA damaging agents:
    • Subjects with a history of Grade 3 or 4 thrombocytopenia or Grade 4 neutropenia while receiving prior therapy with cisplatin, carboplatin, or any of the DNA damaging agents listed above.
    • Part C1:
    • prior platinum therapy for squamous NSCLC
    • Received prior treatment for metastatic NSCLC
    • Part C2:
    • More than 2 prior chemotherapy regimens for the treatment of metastatic breast cancer
    • Any prior platinum therapy for breast cancer in any setting
    • Part C3:
    • In relapsed SCLC, more than 2 prior chemotherapy regimens or, in refractory SCLC, more than 1 prior chemotherapy regimen
    • Has not received at least 1 cycle of platinum based chemotherapy for SCLC
    • Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater from previous anti-cancer therapy or radiotherapy
    • History of brain or leptomeningeal metastases
    • Female subjects who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. Female subjects of childbearing potential must adhere to contraception guidelines
    • Male subjects with partners of child-bearing potential must agree to adhere to contraception guidelines. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded
    • Major surgery =2 weeks before starting study drug, or incomplete recovery from a prior major surgical procedure
    • Serious cardiac or other co-morbid disease, as specified in the protocol
    • Prior bone marrow transplant or extensive radiotherapy to greater than 15% of bone marrow
    • Part C:
    • Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin

    Principal Investigator: Robert Wesolowski, MD

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