Filter Your Search

  • ?
    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.
  • ?
    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

    Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients with Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

    Protocol: OSU-14034

    Eligibility:

    Inclusion Criteria:

    Patients must have histologically confirmed, newly diagnosed or recurrent from a previously treated early stage lung cancers that are locally confined, non-small cell lung cancers that are considered unresectable and for which chemoradiation will be considered definitive therapy; patients with recurrent cancer that is amendable for chemoradiation can be eligible only if patients with prior lobectomy for stage I cancer had not had adjuvant chemotherapy, and more than 8 weeks have elapsed from surgery to allow for wound healing; patients who recur from prior X-ray therapy (XRT) or stereotactic body radiation therapy (SBRT) will not be eligible

    Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam

    Prior thoracic radiation allowed only if there is minimal to no overlap with the treatment area estimated at the time of consultation, and there is no cumulative esophageal dose that exceeds more than 50% of the maximal acceptable dose tolerance

    Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

    Life expectancy of greater than 6 months

    Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

    Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

    Hemoglobin >= 9 g/dL

    Platelets >= 100 x 10^9/L

    Albumin >= 2.5 g/dL

    Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN

    Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min

    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

    Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)

    Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

    Ability to understand and the willingness to sign a written informed consent document

    Activating Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (any G12, G13, Q61) confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified testing

    The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis

    Exclusion Criteria:

    History of another malignancy

    Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above

    History of interstitial lung disease or pneumonitis

    Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment

    Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study

    Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or to either carboplatin or paclitaxel

    Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:

    Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)

    Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis

    Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)

    History or current evidence/risk of retinal vein occlusion (RVO)

    History or evidence of cardiovascular risk including any of the following:

    Left ventricular ejection fraction (LVEF) < LLN

    A QT interval corrected for heart rate using the Bazett’s formula corrected QT (QTcB) >= 480 msec

    History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to registration are eligible)

    History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to registration

    History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system

    Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy

    Known cardiac metastases

    Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)

    HIV-positive patients on combination antiretroviral therapy are ineligible

    Patients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)

    Principal Investigator: Meng X Welliver, MD, PhD

    Learn More
  • 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:

    Inclusion Criteria:

    Disease status

    Parts A and B: Histologically or cytologically 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:

    For Pre-screening:

    Advanced (metastatic or locally-advanced unresectable and not eligible for definitive

    treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung

    cancer (NSCLC)

    Available historical tumor specimen at the time of pre-screening or willing to

    provide a tumor biopsy (core) if the biopsy may be considered as part of standard

    clinical practice for the patient

    Received or did not tolerate standard approved targeted therapy, if appropriate for

    tumor genotype

    For Screening:

    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.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    -Part C3:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC

    that is platinum-resistant, defined as disease progression during initial treatment

    with a platinum-based regimen or progression within 90 days of completion of platinum

    therapy. Subjects with platinum-resistant disease may receive a second-line

    non-platinum-based chemotherapy and subsequently be enrolled to this study. Subjects

    who received and are resistant to a second-line platinum-based chemotherapy may also

    be enrolled into the study.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    WHO performance status of 0 or 1

    Life expectancy of ≥12 week

    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 (6 weeks for nitrosoureas and Mitomycin-C,

    and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,

    whichever greater, before first dose of study drug.

    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.

    Subjects with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia

    while receiving prior therapy.

    Part C1:

    Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One

    additional line of non-platinum based therapy in the advanced setting

    1. Pre-screening Only*: Subjects may currently be receiving platinum-based

    chemotherapy in the advanced setting, or have completed 1 line of

    platinum-based chemotherapy and are currently receiving a second-line

    non-platinum-based therapy or maintenance therapy

    2. There is no restriction on prior immunotherapy or targeted therapy unless

    combined together with a cytotoxic agent

    Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months

    Subjects who are known to be TP53 wild-type, unless they are determined to have

    ATM loss of expression during screening or pre-screening or until all the

    planned subjects with TP53 mutation are enrolled as determined by the medical

    monitor

    Subjects with unknown TP53 mutational status will be enrolled until the group of

    approximately 10 subjects

    Exclusion Criteria:

    Inclusion Criteria:

    Disease status

    Parts A and B: Histologically or cytologically 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:

    For Pre-screening:

    Advanced (metastatic or locally-advanced unresectable and not eligible for definitive

    treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung

    cancer (NSCLC)

    Available historical tumor specimen at the time of pre-screening or willing to

    provide a tumor biopsy (core) if the biopsy may be considered as part of standard

    clinical practice for the patient

    Received or did not tolerate standard approved targeted therapy, if appropriate for

    tumor genotype

    For Screening:

    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.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    -Part C3:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC

    that is platinum-resistant, defined as disease progression during initial treatment

    with a platinum-based regimen or progression within 90 days of completion of platinum

    therapy. Subjects with platinum-resistant disease may receive a second-line

    non-platinum-based chemotherapy and subsequently be enrolled to this study. Subjects

    who received and are resistant to a second-line platinum-based chemotherapy may also

    be enrolled into the study.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    WHO performance status of 0 or 1

    Life expectancy of ≥12 week

    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 (6 weeks for nitrosoureas and Mitomycin-C,

    and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,

    whichever greater, before first dose of study drug.

    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.

    Subjects with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia

    while receiving prior therapy.

    Part C1:

    Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One

    additional line of non-platinum based therapy in the advanced setting

    1. Pre-screening Only*: Subjects may currently be receiving platinum-based

    chemotherapy in the advanced setting, or have completed 1 line of

    platinum-based chemotherapy and are currently receiving a second-line

    non-platinum-based therapy or maintenance therapy

    2. There is no restriction on prior immunotherapy or targeted therapy unless

    combined together with a cytotoxic agent

    Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months

    Subjects who are known to be TP53 wild-type, unless they are determined to have

    ATM loss of expression during screening or pre-screening or until all the

    planned subjects with TP53 mutation are enrolled as determined by the medical

    monitor

    Subjects with unknown TP53 mutational status will be enrolled until the group of

    approximately 10 subjects

    Principal Investigator: Robert Wesolowski, MD

    Learn More
  • open for enrollment

    Ph III Randomized Mk-3475In Muscle Invasive And Locally Advanced Urothelial Carcinoma Versus Observa

    Protocol: ALLIANCE-A031501

    Principal Investigator: Amir Mortazavi, MD

    Learn More
  • open for enrollment

    Daratumumab and Ibrutinib for Symptomatic, Treatment-Naïve CLL: A Phase 1b Proof-of-Concept Study

    Protocol: OSU-17143

    Principal Investigator: Jennifer A Woyach, MD

    Learn More
  • open for enrollment

    ph I/II trial of Venetoclax & BEAM conditioning followed by auto-SCT for pts w/ primary refrac NHL

    Protocol: OSU-17225

    Principal Investigator: Basem M William, MD

    Learn More
  • open for enrollment

    An Open-label, Phase 1b Study of ACP-196 Alone or in Combinatio in Subjects with Follicular Lymphoma

    Protocol: OSU-15029

    Principal Investigator: Beth A Christian, MD

    Learn More