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

    Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery

    Protocol: OSU-13282

    Eligibility:

    Inclusion Criteria:

    COHORT I:

    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    Patient must be > 18 years

    The patient must have clinical node negative, stage I breast cancer

    The surgical treatment must be intended to be a lumpectomy

    The biopsy site must have been demarcated by a clip(s)

    Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging

    Patient must be able to tolerate lying in the prone position with arms extended forward

    Must be able to tolerate MRI scan with contrast

    COHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    COHORT II: Patient must be >= 60 years

    COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive

    COHORT II: Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing

    COHORT II: The patient must have clinical node negative, stage I breast cancer

    COHORT II: The surgical treatment must be intended to be a lumpectomy

    COHORT II: The biopsy site must have been demarcated by a clip(s)

    COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging

    COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy

    COHORT II: Patient must be able to tolerate lying in the prone position with arms extended forward

    COHORT II: Must be able to tolerate MRI scan with contrast

    COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months

    COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI

    COHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

    Exclusion Criteria:

    COHORT II:

    Age < 60 years

    Hormone unresponsive breast cancer

    T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer

    N-1, N-2, or N-3 pathologic axillary nodes

    Mastectomy intended

    Unwilling to undergo anti-endocrine therapy

    Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign

    Non-epithelial breast malignancies such as sarcoma or lymphoma

    Paget’s disease of the nipple

    Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters

    Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment

    Prior breast or thoracic radiation therapy (RT) for any condition

    Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements

    Principal Investigator: Julia White, MD

    Learn More
  • open for enrollment

    Omega-3 Fatty Acids in Preventing Recurrence in Patients with Hormone Receptor-Negative or HER2-Positive Stage 0-III Breast Cancer That Have Completed Treatment

    Protocol: OSU-13130

    Eligibility:

    Inclusion Criteria:

    Prior diagnosis of stage 0 to III breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy

    Completion of chemotherapy or trastuzumab for > six months and of radiation therapy for >= 2 months, as applicable and 2 years or less from completion of standard therapy

    Greater than 1 year from pregnancy, lactation

    Mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the Stefanie Spielman Comprehensive Breast Center or the James Cancer Hospital within the six months prior to study enrollment that are not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered following a negative biopsy

    Must be willing to undergo fine needle aspiration of the contralateral breast for breast adipose tissue at 0, 3, 6, 9 and 12 months of the study and breast epithelial tissue samples at 0, 6 and 12 months of study

    Must be willing to have about 30 ml of blood drawn at 0, 6 and 12 months and about 5-10 ml of blood at 3 and 9 months

    No history of diabetes mellitus or stroke, or bleeding tendency

    Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (fully active or restricted only in physically strenuous activity)

    Hemoglobin >= 9 g/dL

    Platelets >= 100,000/mm^3

    Fasting blood glucose =< 115 mg/dL

    Transaminases (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =< 1.5 x upper limit of normal (ULN)

    Negative pregnancy test for women of childbearing potential

    Exclusion Criteria:

    Other current malignancy or metastatic malignancy of any kind

    Ongoing chemotherapy, radiation therapy, or other cancer-related treatment

    Subjects on Coumadin or other anticoagulants

    Subjects with breast implants

    Subjects who have had radiation to both breasts or who have undergone bilateral mastectomies

    Subjects with insufficient breast adipose tissue and/or parenchymal breast tissue/breast density for adequate FNA sampling as determined by clinical examination and/or mammography

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

    Chronic use of omega-3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements

    Pregnant or nursing women

    Known sensitivity or allergy to fish

    Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products

    Learn More
  • open for enrollment

    Ph I Dose Escalation & Cohort Expansion Study of TSR-042 in Pts w/ Advanced Solid Tumors

    Protocol: OSU-16293

    Principal Investigator: David M O'Malley, MD

    Learn More
  • open for enrollment

    Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

    Protocol: OSU-15172

    Eligibility:

    Inclusion Criteria:

    Histologically- or cytologically-confirmed diagnosis of locally advanced or

    metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

    Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a

    gene rearrangement of interest may be eligible provided they meet all other

    inclusion/exclusion criteria

    For patients enrolled via local molecular testing, an archival or fresh tumor tissue

    (unless medically contraindicated) is required to be submitted for independent

    central molecular testing at Ignyta's CLIA laboratory post-enrollment

    Measurable or evaluable disease

    Patients with CNS involvement, including leptomeningeal carcinomatosis, which is

    either asymptomatic or previously-treated and controlled, are allowed

    Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1,

    or ALK inhibitors in patients who have tumors that harbor those respective gene

    rearrangements)

    Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged

    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are

    prohibited.

    At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior

    chemotherapy or small molecule targeted therapy

    At least 4 weeks must have elapsed since completion of antibody-directed therapy

    Prior radiotherapy is allowed if more than 14 days have elapsed since the end of

    treatment

    Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life

    expectancy of 4 weeks

    Adequate organ function as defined per protocol

    Ability to swallow entrectinib intact

    Other protocol specified criteria

    Exclusion Criteria:

    Current participation in another therapeutic clinical trial

    Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in

    patients who have tumors that harbor those respective gene rearrangements

    Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged

    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are

    prohibited.

    History of other previous cancer that would interfere with the determination of

    safety or efficacy

    Incomplete recovery from any surgery

    History of non-pharmacologically induced prolonged QTc interval

    History of additional risk factors for torsade de pointes

    Peripheral neuropathy Grade ≥ 2

    Known active infections

    Active gastrointestinal disease or other malabsorption syndromes

    Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase

    inhibitor-induced pneumonitis

    Other protocol specified criteria

    Principal Investigator: Gregory A Otterson, MD

    Learn More
  • open for enrollment

    Ph 1, BXQ-350 as a Single Agent by IV w/ Advanced Solid Tumors and Recurrent High-Grade Gliomas

    Protocol: OSU-16182

    Principal Investigator: Vinay K Puduvalli, MD

    Learn More
  • open for enrollment

    PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

    Protocol: OSU-16010

    Eligibility:

    Inclusion Criteria:

    Signed informed consent prior to study specific procedures.

    Age ≥18 years (or per national guidelines).

    Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000

    patients) or Stage III early invasive breast cancer

    Patients with multicentric and/or multifocal and/or bilateral early invasive breast

    cancer are eligible if all histopathologically examined tumors meet pathologic

    criteria for ER+ and/or PR+ and HER2-.

    Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive

    breast cancer.

    Patients must have undergone breast surgery for the current malignancy. FFPE tumor

    tissue block must be confirmed to be received at the central sample repository prior

    to randomization.

    ECOG performance status 0-1.

    Patients must be able and willing to swallow and retain oral medication.

    Serum or urine pregnancy test must be negative in premenopausal women within 14 days

    of randomization, or in women with amenorrhea of less than 12 months at time of

    randomization.

    Patients who received neo/adjuvant therapy must be after last dose of chemotherapy

    and/or biologic therapy and must have sufficient resolution of side effects.

    Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be

    after last dose of radiotherapy and must have sufficient resolution of side effects.

    Patients must have sufficient resolution of any surgical side effects (no active

    wound healing complications).

    -Patients must either be initiating or have already started adjuvant hormonal treatment. -

    Patients who already received neo/adjuvant endocrine therapy are eligible as long as

    they are enrolled within 12 months of initial histological diagnosis and after

    completing no more than 6 months of adjuvant endocrine therapy.

    Absolute neutrophil count ≥ 1,500/µL

    Platelets ≥ 100,000/ mm3

    Hemoglobin ≥ 10g/dL

    Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin

    within normal range in patients with documented Gilbert's Syndrome.

    Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT)

    ≤ 1.5 × institutional ULN.

    Serum creatinine within normal institutional limits or creatinine clearance ≥ 60

    mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

    Exclusion Criteria:

    Concurrent therapy with other Investigational Products.

    Prior therapy with any CDK inhibitor.

    Patients with Stage I or IV breast cancer are not eligible.

    History of allergic reactions attributed to compounds of chemical or biologic

    composition similar to palbociclib.

    Patients receiving any medications or substances that are potent inhibitors or

    inducers of

    CYP3A isoenzymes within 7 days of randomization.

    Uncontrolled intercurrent illness that would limit compliance with study

    requirements.

    Pregnant women, or women of childbearing potential without a negative pregnancy test

    within 14 days prior to randomization.

    -Patients with a history of any malignancy are ineligible (for exceptions see: Pallas -

    Protocol, v1.0, Exclusion criteria 8).

    Patients who previously received endocrine therapy within 5 years prior to diagnosis

    of the current malignancy.

    Patients on combination antiretroviral therapy.

    Patients with clinically significant history of any liver disease.

    Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen

    therapy is allowable).

    Learn More
  • open for enrollment

    Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

    Protocol: OSU-15222

    Eligibility:

    Inclusion Criteria: - Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole) - Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed. - Prior tamoxifen use is allowed - Prior chemotherapy is allowed - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Metastatic malignancy of any kind - Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease - AI use > 21 days prior to study enrollment - Known bleeding disorders - Current use of warfarin or other anticoagulants - 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 situation that would limit compliance with study requirements - Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation - Pregnant or nursing women - Known sensitivity or allergy to fish or fish oil - Unable to give informed consent
    Learn More
  • open for enrollment

    A Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients With Advanced Breast Cancer

    Protocol: OSU-15246

    Eligibility:

    Inclusion Criteria:

    Inclusion Criteria:

    1. Patients must have documented histological or cytological evidence of invasive cancer

    of the breast. Measureable disease is not required.

    2. Phase 1 patients must have TNBC or ER(+) HER2 normal breast cancer and Phase 2

    patients must have AR(+) TNBC or ER(+) HER2 normal breast cancer

    ER positive is defined as positive if ≥1% by IHC

    ER/PgR(-) is defined as negative if 0% by IHC

    HER2 normal is defined as IHC 0-1+ or IHC 2+(and FISH less than 2), or FISH less

    than 2.0

    AR(+) is defined as ≥1% by IHC. The assessment of AR expression may have been

    performed any time in the past. Enrollment may be based on local pathology

    findings with subsequent review of AR expression by central pathology to

    determine if the patient will be considered evaluable for Phase 2. For patients

    without known AR status in Phase 2, AR assessment will be performed as a

    pre-screening test following the signing of a separate non-therapeutic informed

    consent.

    3. Female patients with ER(+)/HER2 normal tumors must be post-menopausal defined as

    cessation of regular menses for at least 12 consecutive months with no alternative

    pathological or physiological cause, and have a serum FSH level within the

    laboratory's reference range for postmenopausal females that are ≥ 60 years old.

    Ovarian suppression with a LHRH agonist or antagonists to achieve cessation of

    regular menses is allowed on study. Male patients with ER(+)/HER2 normal tumors must

    be undergoing gonadal suppression using LHRH agonists or antagonists prior to dosing

    with VT-464 and continue with the LHRH agonist or antagonist for the duration of the

    study.

    4. Patients with ER(+)/HER2 normal tumors must have progression of disease following at

    least 1 prior line of endocrine therapy. Progression of disease within 6 months of

    adjuvant endocrine therapy will be considered a line of prior endocrine therapy.

    Patients in the TNBC - Enzalutamide Treated Cohort (Cohort 2) must have received

    prior enzalutamide for breast cancer.

    5. Availability of a representative, formalin-fixed, paraffin-embedded, tumor specimen

    that enables the definitive diagnosis of breast cancer with adequate viable tumor

    cells in a tissue block (preferred) or ≥ 10 (20 preferred) freshly cut, unstained,

    serial slides and the associated pathology report are required prior to enrollment

    (All Phase 2 patients and Phase 1 patients to be considered part of the Phase 2

    evaluable population).

    6. Patients must ≥ 18 years of age

    7. ECOG PS of 0 or 1

    8. Patients must have adequate hematopoietic function as evidenced by:

    WBC ≥ 3,000/μl

    ANC ≥ 1,500/μl

    Platelet count ≥ 100,000/μl

    HGB ≥ 10 g/dl and not transfusion dependent

    9. Patients must have adequate hepatic function as evidenced by:

    AST/ALT levels ≤ 3X the ULN

    Bilirubin levels of ≤ 2.0 mg/dl

    10. Patients must have adequate renal function as evidenced by a serum creatinine of ≤

    2.0 mg/dl.

    11. Patients must have K+ >3.5 mEq/l.

    12. Women of child-bearing potential must have a negative serum or urine pregnancy test

    within 72 hours of Cycle 1 Day 1. Female patients who are not of childbearing

    potential meet at least one of the following criteria:

    Have undergone a documented hysterectomy and/or bilateral oophorectomy,

    Have medically confirmed ovarian failure, or

    Achieved post-menopausal status, defined as cessation of regular menses for at

    least 12 consecutive months with no alternative pathological or physiological

    cause, and have a serum FSH level within the laboratory's reference range for

    postmenopausal females that are < 60 years old. Ovarian suppression with a LHRH

    agonist to achieve cessation of regular menses is allowed on study.

    13. Women of child-bearing potential and men who have partners of child-bearing potential

    must agree to use two highly effective methods of contraception throughout the study

    and for at least 30 days after the last dose of VT-464 for women and 90 days after

    the last dose of VT-464 for men. Men must also agree to not donate sperm through 90

    days following the last dose of VT-464. For men, one form must be a male condom.

    Exclusion Criteria:

    Inclusion Criteria:

    1. Patients must have documented histological or cytological evidence of invasive cancer

    of the breast. Measureable disease is not required.

    2. Phase 1 patients must have TNBC or ER(+) HER2 normal breast cancer and Phase 2

    patients must have AR(+) TNBC or ER(+) HER2 normal breast cancer

    ER positive is defined as positive if ≥1% by IHC

    ER/PgR(-) is defined as negative if 0% by IHC

    HER2 normal is defined as IHC 0-1+ or IHC 2+(and FISH less than 2), or FISH less

    than 2.0

    AR(+) is defined as ≥1% by IHC. The assessment of AR expression may have been

    performed any time in the past. Enrollment may be based on local pathology

    findings with subsequent review of AR expression by central pathology to

    determine if the patient will be considered evaluable for Phase 2. For patients

    without known AR status in Phase 2, AR assessment will be performed as a

    pre-screening test following the signing of a separate non-therapeutic informed

    consent.

    3. Female patients with ER(+)/HER2 normal tumors must be post-menopausal defined as

    cessation of regular menses for at least 12 consecutive months with no alternative

    pathological or physiological cause, and have a serum FSH level within the

    laboratory's reference range for postmenopausal females that are ≥ 60 years old.

    Ovarian suppression with a LHRH agonist or antagonists to achieve cessation of

    regular menses is allowed on study. Male patients with ER(+)/HER2 normal tumors must

    be undergoing gonadal suppression using LHRH agonists or antagonists prior to dosing

    with VT-464 and continue with the LHRH agonist or antagonist for the duration of the

    study.

    4. Patients with ER(+)/HER2 normal tumors must have progression of disease following at

    least 1 prior line of endocrine therapy. Progression of disease within 6 months of

    adjuvant endocrine therapy will be considered a line of prior endocrine therapy.

    Patients in the TNBC - Enzalutamide Treated Cohort (Cohort 2) must have received

    prior enzalutamide for breast cancer.

    5. Availability of a representative, formalin-fixed, paraffin-embedded, tumor specimen

    that enables the definitive diagnosis of breast cancer with adequate viable tumor

    cells in a tissue block (preferred) or ≥ 10 (20 preferred) freshly cut, unstained,

    serial slides and the associated pathology report are required prior to enrollment

    (All Phase 2 patients and Phase 1 patients to be considered part of the Phase 2

    evaluable population).

    6. Patients must ≥ 18 years of age

    7. ECOG PS of 0 or 1

    8. Patients must have adequate hematopoietic function as evidenced by:

    WBC ≥ 3,000/μl

    ANC ≥ 1,500/μl

    Platelet count ≥ 100,000/μl

    HGB ≥ 10 g/dl and not transfusion dependent

    9. Patients must have adequate hepatic function as evidenced by:

    AST/ALT levels ≤ 3X the ULN

    Bilirubin levels of ≤ 2.0 mg/dl

    10. Patients must have adequate renal function as evidenced by a serum creatinine of ≤

    2.0 mg/dl.

    11. Patients must have K+ >3.5 mEq/l.

    12. Women of child-bearing potential must have a negative serum or urine pregnancy test

    within 72 hours of Cycle 1 Day 1. Female patients who are not of childbearing

    potential meet at least one of the following criteria:

    Have undergone a documented hysterectomy and/or bilateral oophorectomy,

    Have medically confirmed ovarian failure, or

    Achieved post-menopausal status, defined as cessation of regular menses for at

    least 12 consecutive months with no alternative pathological or physiological

    cause, and have a serum FSH level within the laboratory's reference range for

    postmenopausal females that are < 60 years old. Ovarian suppression with a LHRH

    agonist to achieve cessation of regular menses is allowed on study.

    13. Women of child-bearing potential and men who have partners of child-bearing potential

    must agree to use two highly effective methods of contraception throughout the study

    and for at least 30 days after the last dose of VT-464 for women and 90 days after

    the last dose of VT-464 for men. Men must also agree to not donate sperm through 90

    days following the last dose of VT-464. For men, one form must be a male condom.

    Principal Investigator: Bhuvaneswari Ramaswamy, MD

    Learn More
  • open for enrollment

    A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors

    Protocol: OSU-16195

    Eligibility:

    Inclusion Criteria:

    For Dose Escalation:

    Subjects with any previously treated advanced (metastatic or refractory) solid

    tumor

    For Cohort Expansion:

    Subjects must have a previously treated advanced solid tumor to be eligible

    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy

    Women of child-bearing potential and men must use an acceptable method of

    contraception during treatment and for 23 weeks after treatment for women and 31

    weeks for men

    Exclusion Criteria:

    Known central nervous system metastases or central nervous system as the only source

    of disease

    Other concomitant malignancies (with some exceptions per protocol)

    Active, known or suspected autoimmune disease

    Uncontrolled or significant cardiovascular disease

    History of active or chronic hepatitis (e.g. Hep B or C)

    Impaired liver or bone marrow function

    Major surgery less than 1 month before start of the study

    Principal Investigator: David M O'Malley, MD

    Learn More