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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

    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

    NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases

    Protocol: OSU-11156

    Eligibility:

    Inclusion Criteria:

    • Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

    RAEB-1 or RAEB-2 fitting within one of the following disease groups:

    • Primary induction failure (PIF): Patients who have not achieved a complete remission (CR) after two induction cycles of cytotoxic therapy (i.e. 7+ 3, MEC, FLAG, etc.) and having = 10,000 absolute circulating blasts measured at least 21 days from prior therapy. Hydroxyurea may be used to control blasts count. Demethylating agents do not count as induction therapy; however early re-induction therapy based on residual disease on a day 14 BM will count as a 2nd cycle
    • Relapsed Disease with low disease burden (AML or MDS with = 10,000 absolute circulating blasts. No re-induction attempts are required, but a maximum of 2 reinduction attempts are allowed to be eligible.
    • CR3 or greater: This will include CRp defined as CR without platelet recovery to 100,000/mcL.
    • CR1 or CR2 with high risk features: Includes therapy induced, prior MDS or MPD, high risk cytogenetic or molecular phenotype with no available donor (sibling or unrelated adult)

    Patients with known prior central nervous system (CNS) involvement are eligible provided that it has been treated and CSF is clear for at least 2 weeks prior to enrollment. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment.

    • Available related HLA-haploidentical adult donor by at least Class I serologic typing at the A&B locus
    • Karnofsky score > 50%
    • Adequate organ function within 28 days of study registration defined as:
    • Hepatic: AST = 3 x upper limit of institutional normal, total bilirubin = 2.0 mg/dl
    • Renal: estimated glomerular filtration rate (GFR) = 50 mL/min/1.73m^2
    • Pulmonary: Oxygen saturation = 90% on room air and DLCOcor = 40%
    • Cardiac: Ejection Fraction = 35% and no uncontrolled angina, severe uncontrolled ventricular or arterial arrhythmias, or any evidence of acute ischemia or active conduction system abnormalities (rate controlled atrial fibrillation is not an exclusion)
    • Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (except for those prescribed as part of the study)
    • Women of child bearing potential must have a negative pregnancy test within 28 days prior to study registration and agree to use adequate birth control during study treatment
    • Voluntary written consent

    Exclusion Criteria:

    • Biphenotypic leukemia
    • Allogeneic transplant for AML within previous 6 months
    • New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy, if feasible. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
    • Uncontrolled bacterial, fungal or viral infections including HIV - chronic asymptomatic viral hepatitis is allowed
    • Known hypersensitivity to any of the study agents
    • Received any investigational drugs within the 14 days before 1st dose of fludarabine
    • Requires agents other than hydroxyurea to control blast count

    Donor Selection:

    • Related donor (sibling, parent, offspring, parent or offspring of an HLA identical sibling) 12-75 years of age. (It is recognized individual institutions may have differing donor age guidelines. This is acceptable as long as no donor is younger than 12 years or older than 75 years).
    • Body weight of at least 40 kilograms
    • In general good health as determined by the medical provider
    • HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A&B locus
    • Able and willing to have up to 4 separate apheresis collections
    • Not pregnant
    • Voluntary written consent

    Principal Investigator: Sumithira Vasu, MD

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  • open for enrollment

    A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    Protocol: OSU-13140

    Eligibility:

    Inclusion Criteria:

    • Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
    • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
    • Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for >= 6 months after the last dose
    • Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a complete response (CR) or partial response (PR)
    • Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs >=9 months from the first dose)
    • Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
    • Able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
    • Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
    • Laboratory values within protocol -defined parameters
    • Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
    • Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
    • Have a negative urine or serum pregnancy test at screening
    • Agrees to protocol-defined use of effective contraception

    Exclusion Criteria:

    • Diagnosis of ovarian carcinoma with mucinous histology
    • Had more than 2 prior lines of chemotherapy
    • Prior exposure to trabectedin or hypersensitivity to any of the excipients
    • Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
    • Unwilling or unable to have a central venous catheter placed
    • Pregnant or breast-feeding
    • Less than 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy
    • History of another neoplastic disease (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years
    • Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
    • Known history of central nervous system metastasis
    • Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
    • Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
    • Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
    • Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

    Protocol: OSU-15003

    Eligibility:

    Inclusion Criteria:

    • diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
    • have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

    Exclusion Criteria:

    • Active multiple myeloma,requiring treatment as defined by the study protocol
    • Primary systemic AL (immunoglobulin light chain) amyloidosis
    • Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with bone-protecting agents (eg, bisphosphonates, denosumab) or corticosteroids with a dose not exceeding 10 mg prednisone per day or equivalent are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
    • history of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
    • known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
    • any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study

    Principal Investigator: Craig C Hofmeister, MD, Affiliate

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  • open for enrollment

    Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

    Protocol: OSU-13128

    Eligibility:

    Inclusion Criteria:

    • Patients have evidence of relapse or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease as defined by any of the following:
    • Serum M-protein >= 0.5 g/dl (>= 10 g/l)
    • Urine monoclonal protein >= 200 mg/24h
    • Involved free light chain (FLC) level >= 10mg/dl (>= 100mg/l) and an abnormal serum free light chain ratio (< 0.26, or > 1.65)
    • Measurable biopsy proven plasmacytoma (should be measured within 28 days of initial investigational agent dosing)
    • Patients must have had at least 2 prior line of therapy
    • Patients must not have had progression of disease on lenalidomide 25 mg; stable disease on lenalidomide is permitted
    • Patient may be enrolled at any time from last line of therapy
    • Absolute neutrophil count (ANC) > 1000/uL
    • Platelets >= 75,000/uL, if plasma cell percentage on bone marrow biopsy aspirate or core is > 30%, platelet eligibility requirement will be adjusted to 60,000/uL
    • Total bilirubin =< 1.5 mg/dL
    • Alkaline phosphatase =< 3 X the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 X the ULN
    • Serum creatinine =< 2 mg/dL or calculated creatinine clearance of >= 40 ml/min within 14 days of registration using Modification of Diet in Renal Disease (MDRD) formula
    • Patient must be able to swallow capsule or tablet
    • Patients must provide informed consent
    • Patients must have a left ventricular ejection fraction > 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
    • Patients must have a Karnofsky performance status >= 70
    • A negative pregnancy test will be required for all women of child bearing potential; breast feeding is not permitted
    • Fertility requirements:
    • Female patients with child bearing potential must have a negative pregnancy test at least 7 days before starting treatment drugs
    • Male patients must agree to use an adequate method of contraception for the duration of the study and for 90 days afterwards
    • Female patients must be either posy-menopausal, free from menses >= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from sexual activity starting from screening and for 90 days afterwards
    • Female patients of child bearing potential must agree to comply with the fertility and pregnancy test requirements dictated by the Rev-Assist program

    Exclusion Criteria:

    • Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
    • Prior exposure to anti programmed cell death 1 (PD1) or anti programmed cell death 1 ligand 1 (PDL1)
    • Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
    • History of allergic reaction (including erythema nodosum) to lenalidomide
    • Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
    • Patients with contraindication to thromboprophylaxis
    • Unacceptable cardiac risk factors defined by any of the following criteria: patients with congenital long QT syndrome, any history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate (HR) < 50 bpm, left ventricular ejection fraction < 30%
    • Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies
    • Patients who have undergone major surgery =< 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery
    • Patients with known positivity for human immunodeficiency virus (HIV), or hepatitis C; baseline testing for HIV and hepatitis C is not required
    • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from a prior malignancy for >= 5 yrs and are considered by their physician to be less than 30% risk of relapse
    • Patients with active (untreated or relapsed) central nervous system (CNS) metastasis of the patient's myeloma
    • Patients with a history of gastrointestinal surgery or other procedure that might, in the opinion of the investigator(s), interfere with the absorption or swallowing of the study drugs
    • Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff
    • Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

    Principal Investigator: Yvonne A Efebera, MD, Affiliate

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  • open for enrollment

    Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

    Protocol: OSU-14298

    Eligibility:

    Inclusion Criteria:

    • Participant must have documented multiple myeloma and measurable disease defined as: 1) monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma; 2) measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >=0.5 g/dL or urine M-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
    • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
    • Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
    • Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing
    • Man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab

    Exclusion Criteria:

    • Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
    • Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
    • Participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
    • Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
    • Participant has had radiation therapy within 14 days of randomization
    • Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed). Participants with known or suspected COPD or asthma must have a FEV1 test during Screening
    • Participant is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have active hepatitis B or hepatitis C

    Principal Investigator: Ashley Rosko, MD

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  • open for enrollment

    GSK2141795, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

    Protocol: SWOG-S1221

    Eligibility:

    Inclusion Criteria:

    • PHASE I PORTION ELIGIBILITY CRITERIA
    • Patients must have BRAF^V600 mutant metastatic cancer irrespective of the histology or prior therapy; BRAF^V600 mutant status must be documented by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory may also be accepted
    • Patients must have locally advanced unresectable stage IIIC or metastatic stage IV cancer with either progression to prior therapy or a newly diagnosed cancer that does not have an available treatment with curative intent
    • Patients must have a complete physical examination and medical history within 28 days prior to registration
    • Patients must have measurable or non-measurable disease; all measurable lesions must be assessed (by physical examination, computed tomography [CT], or magnetic resonance imaging [MRI] scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
    • All patients must undergo a CT or MRI of the brain within 42 days prior to registration; patients with asymptomatic brain metastases or previously treated brain metastases that are stable (i.e. not requiring corticosteroids) at the time of registration will be eligible
    • Patients may have received prior systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens); all adverse events associated with prior treatment must have resolved to =< grade 1 prior to registration
    • Patients progressing on a prior BRAF inhibitor-based therapy will be eligible, as are patients naïve to BRAF inhibitor therapy; resistance to BRAF inhibitor-based therapy will be defined as progressive disease by RECIST 1.1 criteria while receiving therapy with a BRAF inhibitor (vemurafenib or dabrafenib, alone or in combination with a mitogen-activated protein kinase [MEK] inhibitor); this may be innate resistance (patients who never achieved a tumor response while on BRAF inhibitor therapy) or acquired resistance (progression after having a tumor response to BRAF inhibitor therapy); there will not be a period of break between progression on the prior BRAF inhibitor-based therapy and the start of dabrafenib and GSK2141795
    • Patients may have received prior surgery (for both the primary and stage IV disease); all adverse events associated with prior surgery must have resolved to =< grade 1 prior to registration
    • Patients may have received prior radiation therapy; all adverse events associated with prior radiation therapy must have resolved to =< grade 1 prior to registration
    • Patients must be willing to submit blood for pharmacokinetics; sites must order S1221 pharmacokinetic (PK) kit immediately after registration; the Southwest Oncology Group (SWOG) patient identification (ID) number must be provided on the S1221 PK Kit request form
    • Patients must have available and be willing to submit baseline tissue taken at the time of disease progression to prior BRAF inhibitor-based therapy (either fresh frozen [preferred], or paraffin-embedded tumor blocks) OR must have a site of disease that can be biopsied within this study for translational medicine studies; tissue may be from an archival biopsy or a new biopsy after the patient has been registered to the protocol; since patients are referred to this protocol after progression on prior BRAF inhibitor-based therapy, the biopsy taken at the time of progression will be used as the baseline biopsy for this study; patients must be willing to submit plasma and whole blood for translational medicine studies
    • Patients must have Zubrod performance status =< 1
    • Absolute neutrophil count (ANC) >= 1,200/ul
    • Platelets >= 100,000/ul
    • Hemoglobin >= 9 g/dL
    • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert's syndrome)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases)
    • Serum albumin >= 2.5 g/dL
    • Serum creatinine =< 1.5 mg/dL OR measured or calculated creatinine clearance >= 50 mL/min
    • Patient must have a left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days prior to registration
    • Patients must not have a corrected QT (QTc) interval >= 480 msecs within 28 days prior to registration
    • Patients must not have a history of acute coronary syndromes (including unstable angina), myocardial infarction within 6 months, coronary angioplasty, or stenting within the past 24 weeks; class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; or history of known cardiac arrhythmias (such as atrial fibrillation) unless it has been stably controlled for > 30 days prior to registration; abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (subjects with Grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; subjects with moderate valvular thickening are not eligible
    • Patients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registration
    • Patients with human immunodeficiency virus (HIV) are eligible if they are not on antiviral agents and have adequate cluster of differentiation (CD)4 counts (>= 500 mm^3)
    • Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range
    • At the time of registration, patients must not be receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); patients must not be planning to use herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1)
    • Women of childbearing potential must have a negative pregnancy test within 14 days of registration
    • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
    • Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, previously diagnosed type 1 diabetes mellitus/type 2 diabetes, psychiatric illness/social situations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, that would limit compliance with study requirements; patients must not have any evidence of mucosal or internal bleeding; patients must not have received any major surgery within four weeks prior to registration
    • Patients must not have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
    • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib or other agents used in this study including dimethyl sulfoxide (DMSO)
    • Patients must be able to retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels; patients who have feeding tubes can enroll in the study provided that the capsules do not need to be modified
    • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
    • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
    • Patients must have a serum albumin >= 2.5 g/dL within 28 days prior to registration
    • Patients with known history or current evidence of retinal vein occlusion (RVO) are not eligible:
    • History of RVO, or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
    • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO such as:
    • Evidence of new optic disc cupping
    • Evidence of new visual field defects
    • Intraocular pressure > 21 mmHg
    • NOTE: Ophthalmic exam is required for all patients; exam must be obtained within 28 days prior to registration
    • Patients must not have uncontrolled hypertension (defined as systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg which cannot be controlled by anti-hypertensive therapy)
    • PHASE II PORTION ELIGIBILITY CRITERIA
    • Patients must have histologically confirmed melanoma with BRAF^V600 mutation; patients must have stage IIIC or stage IV disease
    • Patients must have received prior BRAF inhibitor therapy (e.g. dabrafenib, vemurafenib) within 56 days prior to registration; prior trametinib therapy is permitted; patients are not required to interrupt BRAF or MEK inhibitor therapy prior to the initiation of three agent combination therapy on study
    • Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)
    • Patients must have Zubrod performance status =< 2
    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: Prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility
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  • open for enrollment

    ACP-196 in Combination With Pembrolizumab, for Treatment of B-Cell Malignancies

    Protocol: OSU-14272

    Eligibility:

    Main Inclusion Criteria:

    • Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
    • Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
    • Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children.

    Exclusion Criteria

    • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
    • Central nervous system (CNS) involvement by lymphoma/leukemia
    • Any therapeutic antibody within 4 weeks of first dose of study drugs.
    • The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is < 5 times the half-life of the previously administered agent(s).
    • ANC < 0.5 x 10^9/L or platelet count < 50 x 10^9/L unless due to disease involvement in the bone marrow.
    • Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN.

    Principal Investigator: John C Byrd, MD

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  • open for enrollment

    Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

    Protocol: OSU-07061

    Eligibility:

    Inclusion Criteria:

    • Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
    • Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
    • Written informed consent and/or Consent waiver by institutional review board (IRB)

    Exclusion Criteria:

    • Unexplained fever and/or untreated, active infection
    • Patient pregnancy
    • Previous head and neck surgery precluding transoral/robotic procedures
    • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
    • Inability to grant informed consent
    • INTRAOPERATIVE EXCLUSION CRITERIA:
    • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
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  • open for enrollment

    A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

    Protocol: OSU-14014

    Eligibility:

    Inclusion Criteria:

    • Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
    • Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
    • Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
    • Must be able to read and understand informed consent
    • Adequate birth control methods for the duration of the study

    Exclusion Criteria:

    • Current mucositis.
    • Prior radiation to the head and neck.
    • Chemotherapy treatment within the previous 12 months.
    • Tumors of the lips, sinuses, salivary glands or nasopharynx.
    • Unknown primary tumor.
    • Stage 4c metastases.
    • Evidence of significant hepatic, hematologic, or immunologic disease.
    • Women who are pregnant or breast-feeding.
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