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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

    Ph III Memantine & Whole-Brain Radiotherapy W/ Or W/Out Hippocampal Avoidance In Pts W/ Brain Mets

    Protocol: NRG-CC001

    Principal Investigator: Evan J Wuthrick, MD

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  • open for enrollment

    TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

    Protocol: RTOG-3501

    Eligibility:

    Inclusion criteria:

    • Patients must have histologically or cytologically confirmed diagnosis (from primary lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or larynx (For patients with oropharynx primary, the tumor must be negative for p16 by immunohistochemistry).
    • Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3p16 negative oropharynx cancer or T1-2 any N hypopharynx cancer) including no distant metastases.
    • History/Physical examination by a Radiation Oncologist and Medical oncologist prior to entering the study.
    • Examination by an ENT or Head & Neck Surgeon including laryngopharyngoscopy prior to entering the study.
    • Patients must have a chest CT scan, or PET/CT scan to rule out metastatic disease
    • Patients must have a CT scan, MRI, or PET/CT scan of the tumor site and neck nodes prior to entering the study.
    • Patients must have an EKG and ECHO or MUGA scan prior to entering the study.
    • Patients must have Zubrod Performance Status of 0-1.
    • Patients must be ≥ 18 years of age.
    • Patients must have normal organ and marrow function as defined below:
    • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 8.0 g/dl
    • Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
    • Total bilirubin < 2 x the institutional upper limit of normal
    • AST or ALT ≤ 3 x the institutional upper limit of normal
    • Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
    • Women of childbearing potential must have a negative pregnancy test prior to registration.
    • Patients of reproductive potential must practice effective contraception while on study and for at least 60 calendar days following treatment.
    • All patients must sign an informed consent prior to enrollment.
    • Patients must comply with the treatment plan and follow-up schedule.

    Exclusion criteria:

    • Patients with simultaneous primaries or bilateral tumors.
    • Patients who have had gross total excision of the primary tumor.
    • Patients with initial surgical treatment, radical or modified neck dissection.
    • Patients who received prior systemic chemotherapy for the study cancer.
    • Patients who received prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
    • Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
    • Prior allergic reaction to the study drugs.
    • Patients who have had prior therapy that specifically and directly targets the EGFR/HER2 pathway.
    • Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment);
    • Pregnant women or sexually active patients not willing or able to use medically acceptable forms of contraceptive method while on treatment.
    • Patients with severe, active co-morbidity, defined as follows:
    • Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Left ventricular ejection fraction < 45%
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 calendar days prior to registration
    • Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
    • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition

    Principal Investigator: Maura L Gillison, MD, PhD

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  • open for enrollment

    Ph 1b Stdy of AT13387 in Combo w/ Paclitaxel in Pts w/ Advanced, Triple Negative Breast Cancer

    Protocol: OSU-15149

    Principal Investigator: Robert Wesolowski, MD

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  • open for enrollment

    Ph 2 Entrectinib for Pts w/ Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

    Protocol: OSU-15172

    Principal Investigator: Gregory A Otterson, MD

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  • open for enrollment

    Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

    Protocol: OSU-13219

    Eligibility:

    Inclusion Criteria:

    • Patients with a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndromes (MDS) with fewer than 10% myeloblasts or lymphoblasts in the bone marrow and no blasts in the peripheral blood on morphologic analysis performed within 30 days of start of the conditioning regimen; if remission bone marrow is available beyond 30 days a new bone marrow evaluation is required to assess remission status
    • The diagnosis of AML, ALL, or MDS will be based on World Health Organization (WHO) criteria
    • Pre-transplant bone marrow sample must be evaluable for assessment of remission status (i.e. aspirate smear containing particles and/or evaluable bone marrow core biopsy)
    • Patients with leukemia infiltration in the central nervous system (CNS) are eligible if cerebrospinal fluid (CSF) cytospin is negative for myeloblasts or lymphoblasts at time of enrollment
    • If the patient has an intra-abdominal chloroma on presentation, and has a partial response or complete response to treatment (size reduction of chloroma and marrow blast < 10%), the patient is eligible; however the chloroma must be included as part of the treatment target
    • For patients receiving treatment of their AML, MDS or ALL prior to transplantation:
    • Interval between the start of a cycle of conventional cytotoxic chemotherapy and the start of conditioning regimen must be at least 30 days
    • Interval between completing treatment with a hypomethylating agent or other non-cytotoxic chemotherapy and the start of conditioning regimen must be at least 10 days
    • Hematopoietic Cell Transplantation-Specific Comorbidity Index score (HCT-CI) =< 4 for patients in Cohort 1 and > 4 for Cohort 2
    • Patient must be able to lie still in full body cast for 45 minutes
    • Must have a suitable donor defined as a sibling matched at 5/6 or 6/6 antigens (human leukocyte antigen [HLA]-A, B, and DRB1) or an unrelated volunteer matched at 7/8 or 8/8 HLA alleles (HLA-A, B, C, and DRB1)
    • Signed informed consent
    • DONOR: "High resolution" typing at HLA-A, B, C and DRB1 alleles
    • Single antigen mismatch for siblings and single allele mismatch for volunteer unrelated donors is acceptable
    • Donors must be >= 17 years of age

    Exclusion Criteria:

    • Circulating peripheral blood myeloblasts or lymphoblasts on morphologic analysis from time of last treatment to time of enrollment
    • Prior allograft or prior autograft
    • Active CNS disease as identified by positive CSF cytospin at time of enrollment
    • Karnofsky performance score < 70
    • Symptomatic uncontrolled coronary artery disease or ejection fraction < 40%
    • Total bilirubin >= 2 x the upper limit of normal
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >= 3 x the upper limit of normal
    • Diffusion capacity of the lung for carbon monoxide (DLCO) < 40%
    • Forced expiratory volume in one second (FEV1) < 50% (corrected for hemoglobin)
    • Receiving supplementary continuous oxygen
    • Creatinine clearance < 50 mL/min/1.73m^2
    • Patients with active uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms)
    • Patients seropositive for the human immunodeficiency virus (HIV)
    • Females who are pregnant or breastfeeding
    • Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment
    • Patients who had prior radiation to more than 20% bone marrow containing areas or to any areas exceeding 2000 cGy
    • DONOR:
    • Donors will be excluded if they are an identical twin of the recipient
    • Females who are pregnant (positive serum beta human chorionic gonadotropin beta [β HCG]) or uninterruptible breastfeeding
    • HIV seropositive
    • Donors receiving experimental therapy or investigational agents unless approved by the protocol chair
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  • open for enrollment

    Ph II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squ Cell Lung Ca (Screening St

    Protocol: SWOG-S1400

    Eligibility:

    Inclusion Criteria:

    • SCREENING REGISTRATION:
    • Patients must have pathologically proven squamous cell non-small cell lung cancer (NSCLC) confirmed by tumor biopsy and/or fine-needle aspiration; disease must be either advanced, incurable stage IIIB or stage IV NSCLC; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies will be allowed provided that they contain >= 50% of the squamous component
    • Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen
    • Patients must have adequate tumor tissue available (defined as >= 20% tumor cells as confirmed by the treating institution's local pathologist); patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling; if archival tumor is used either a tumor block or at a minimum 12 formalin-fixed paraffin-embedded (FFPE) slides 4-5 microns thick are required, but 20 slides are strongly recommended; in the event that patient's archival tumor material is derived from a fine needle aspirate and the tumor material from fine needle aspirate or from core needle biopsy is exhausted a new fresh tumor biopsy will be obtained and will be formalin fixed and paraffin-embedded
    • Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion; in addition, patients whose biomarker profiling results indicate the presence of an EGFR mutation or ALK fusion will be notified that they are not eligible for any of the sub-studies
    • Patients must have Zubrod performance status =< 2 documented within 28 days prior to screening registration
    • Patients must also be offered participation in banking for future use of specimens
    • Patients must be willing to provide prior smoking history
    • 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
    • SUB-STUDY ASSIGNMENT:
    • Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible
    • Patients must be registered to the assigned sub-study within 28 calendar days of receiving sub-study assignment from the statistical center
    • Patients must have measurable disease, documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; if patient has measurable disease it must assessed within 28 days prior to sub-study treatment arm randomization; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients with active new disease growth in previously irradiated site are eligible
    • Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study treatment arm randomization; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 28 days following treatment, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to randomization
    • Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen; patients must not have received any prior systemic chemotherapy or investigational drug within 21 days prior to sub-study treatment arm randomization; patients must have recovered (=< grade 1) from any side effects of prior therapy; localized palliative radiotherapy >= 14 days is allowed
    • Patient must have fully recovered from the effects of prior surgery prior to sub-study treatment arm randomization
    • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
    • Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to sub-study treatment arm randomization
    • Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study treatment arm randomization
    • Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study treatment arm randomization
    • Serum bilirubin =< 2 X institutional upper limit of normal (IULN) within 28 days prior to sub-study treatment arm randomization
    • Either serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transferase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN within 28 days prior to sub-study treatment arm randomization (if both SGOT and SGPT are done, both must be =< 2 IULN)
    • For patients with liver metastases, bilirubin and either SGOT and SGPT must be =< 5 x IULN
    • Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 cc/min using the following Cockroft-Gault Formula within 28 days prior to sub-study treatment arm randomization
    • Patients must have Zubrod performance status =< 2 documented within 28 days prior to sub-study treatment arm randomization
    • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
    • Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
    • Patients must not have a known history of human immunodeficiency virus (HIV) seropositivity
    • Prestudy history and physical must be obtained within 28 days prior to sub-study treatment arm randomization
    • 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 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
    • S1400A:
    • Patients must not have any prior exposure to immunotherapy such as, but not limited to other anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), anti-programmed cell death (PD)-1, or anti-PD-L1 antibodies excluding vaccines within 28 days prior to sub-study treatment arm randomization
    • Patients must not have received or be planning to receive any anti-cancer therapy whether chemotherapy, or biologic therapy, therefore receipt of the last dose of anti-cancer therapy, (chemotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) > 21 days prior to randomization (> 14 days prior to randomization for patients who have received prior TKIs [e.g. erlotinib, gefitinib, or crizotinib] and > 42 days for nitrosoureas or mitomycin-c)
    • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable; patients must not have received or be planning to receive any immunosuppressive medication within 28 days prior to sub-study treatment arm randomization, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
    • Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study treatment arm randomization; patients with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded
    • Patients must not have any history of primary immunodeficiency
    • Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1
    • Patients must not have any history of organ transplant that requires use of immunosuppressives
    • Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation
    • Patients must not have a known history of tuberculosis
    • Patients must not have received a live attenuated vaccination within 28 days prior to sub-study treatment arm randomization
    • Patients must not have known HIV, hepatitis B or C positivity
    • S1400B:
    • Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study treatment arm randomization
    • Fasting glucose < 125 mg/dl obtained within 28 days prior to sub-study treatment arm randomization
    • Patients must not have Type 1 or 2 diabetes which requires insulin
    • Patients must not have active or a history of small or large intestine inflammation such as Crohn's disease or ulcerative colitis
    • Patients must not require daily supplemental oxygen
    • Patients must be able to take oral medications; patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of GDC-0032 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
    • Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates
    • Patients must not have received prior treatment of docetaxel as part of frontline platinum-containing chemotherapy (S1400B)
    • S1400C:
    • Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment, CYP3A4 inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
    • Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval
    • Patients must not have QTc > 480msec (based on the mean value of the triplicate electrocardiograms [ECGs]), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
    • Patients must not have uncontrolled electrolyte disorders which can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia)
    • Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of palbociclib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
    • Patients must not have received prior treatment of docetaxel as part of frontline platinum-containing chemotherapy (S1400C)
    • S1400D:
    • Patients must be >= 25 years of age (skeleton maturation is complete)
    • Patients must not be taking, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment drugs, herbal supplements and/or foods known to modulate CYP3A4 or cytochrome p450, family 2, subfamily D, polypeptide 6 (CYP2D6) enzyme activity and drugs that are known to be CYP3A4 substrates
    • Patients must not have received Nitrosourea or mitomycin C within 42 days prior to sub-study treatment arm randomization
    • Patients must not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology
    • Patients must not have a mean resting corrected QT interval (QTc) > 450 msec obtained from 3 consecutive electrocardiograms (ECGs); any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); nor any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
    • Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD4547 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
    • Patients must not have a history of hypersensitivity to active or inactive excipients of AZD4547 or drugs with a similar chemical structure or class to AZD4547
    • Patients
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  • open for enrollment

    Ph 1 MRG-106 following intratumoral/ subcut injection in pt w/ CTCL mycosis fungoides sub-type

    Protocol: OSU-15182

    Principal Investigator: Pierluigi Porcu, MD

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