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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

    Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients with Stage II-III Breast Cancer Undergoing Surgery

    Protocol: ALLIANCE-A011106

    Eligibility:

    Inclusion Criteria:

    Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    Postmenopausal, verified by:

    Post bilateral surgical oophorectomy, or

    No spontaneous menses >= 1 year or

    No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards

    Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy

    Clinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node

    Primary tumor must be:

    Palpable

    Its largest tumor diameter is > 2.0 cm by physical examination or by radiological assessment

    Bi-dimensional measurement by tape, ruler or caliper technique must be provided

    • Note:

    *** Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible

    *** Patients with multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible; if the other lesions have been biopsied (biopsy not required) they must meet the estrogen receptor/human epidermal growth factor receptor 2 (ER/HER2) eligibility requirements; research biopsies and Ki67 assessment and radiological measures are to be performed on the dominant breast lesion

    Invasive breast cancer is estrogen receptor (ER) positive with an Allred score of 6, 7 or 8 by local institution standard protocol; if an Allred score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible; if ER positivity is =< 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred score to determine eligibility

    Invasive breast cancer is human epidermal growth factor receptor 2 (HER2) negative; a patient is considered to have HER2 negative breast cancer if one of the following if one of the following applies:

    0 or 1+ by immunohistochemistry (IHC) and in situ hybridization (ISH) not done

    0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2

    2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2

    Documentation of mammogram and ultrasound (including ductal carcinoma in situ [DCIS] and invasive cancer) of the diseased breast performed within 56 days prior to registration; mammogram for the unaffected contralateral breast is required within 12 months prior to registration

    Absolute neutrophil count (ANC) > 1,000/mm^3

    Platelet count > 100,000/mm^3

    Total bilirubin < 1.5 x upper limits of normal (ULN)

    Creatinine < 1.5 x ULN

    Serum alanine aminotransferase (ALT) < 2.5 x ULN

    Tissue acquisition: patient must agree to provide the required research biopsies at baseline, week 4 and at surgery for integral and integrated biomarker and correlative studies

    Exclusion Criteria:

    Premenopausal status

    Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)

    An excisional biopsy of this breast cancer

    Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration

    Tumor ER Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0

    Surgical axillary staging procedure prior to study entry; Note: fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted

    Clinical or radiographic evidence of metastatic disease; metastatic workup is not required, but is recommended for patients with clinical stage III disease; Note: isolated ipsilateral supraclavicular node involvement is permitted

    Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion

    Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry

    History of invasive breast cancer or contralateral DCIS

    Principal Investigator: Bhuvaneswari Ramaswamy, MD

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  • open for enrollment

    Studying the Physical Function and Quality of Life before and after Surgery in Patients with Stage I Cervical Cancer

    Protocol: GOG-0278

    Eligibility:

    Inclusion Criteria:

    Patient must consent for the appropriate surgery

    Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade

    All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm

    Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging

    Patients who have met the pre-entry requirements

    Patients must have signed an approved informed consent and authorization permitting release of personal health information

    Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

    Exclusion Criteria:

    Patients with stage IA1 disease who are LVSI negative

    Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm

    Patients with >= stage IB2 disease

    Patients with clear cell or neuroendocrine cell types

    Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)

    Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Methods Project 4: Clinical Trial

    Protocol: OSU-14104

    Eligibility:

    Inclusion Criteria: - Male or female subjects who are at least 18 years of age; - Daily smoker; - Generally good health; - Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products); Exclusion Criteria: - Unstable health - Pregnant or breastfeeding (due to toxic effects from tobacco products). - Unable to read for comprehension or completion of study documents.

    Principal Investigator: Peter Shields, MD

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  • open for enrollment

    MRI and Mammography before Surgery in Patients with Stage I-II Breast Cancer

    Protocol: ALLIANCE-A011104

    Eligibility:

    Inclusion Criteria:

    Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0); diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded

    Patients must have either:

    Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry [IHC] staining) and HER-2 negative breast cancer OR

    ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors

    HER2 status will be determined per the 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines:

    • HER2 is considered positive if a) there is IHC 3+ staining or b) positive using either single probe in situ hybridization (ISH) or dual probe ISH
    • HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH

    No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)

    No patients with bilateral breast cancer

    No patients with known deleterious mutations in breast cancer (BRCA) genes

    No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures

    No history of chemotherapy for cancer within 6 months prior to registration

    No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery

    Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram; women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial

    No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed can be enrolled

    Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):

    No history of untreatable claustrophobia

    No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)

    No history of sickle cell disease

    No contraindication to intravenous contrast administration

    No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance

    No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30

    mL/min/1.73 m^2 based on a serum creatinine level obtained within 7 days prior to registration

    Weight lower than that allowable by the MRI table

    No prior MRI of study breast within the 12 months prior to registration

    Non-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential

    Signed study-specific informed consent prior to registration

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  • open for enrollment

    Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients with Locally Advanced Squamous Cell Cancer of the Vulva

    Protocol: GOG-0279

    Eligibility:

    Inclusion Criteria:

    Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva

    Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy

    Absolute neutrophil count (ANC) >= 1,500/mcl

    Platelets >= 100,000/mcl

    Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min

    Bilirubin =< 1.5 x ULN

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN

    Alkaline phosphatase =< 3 x ULN

    Patients judged capable of tolerating a radical course of chemoradiation therapy

    Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population

    Patients must have signed an approved informed consent and authorization permitting release of personal health information

    Patients with a GOG performance status of 0, 1, or 2

    Exclusion Criteria:

    Patients with recurrent carcinoma of the vulva regardless of previous treatment

    Patients who have received prior pelvic radiation or cytotoxic chemotherapy

    Patients with vulvar melanomas or sarcomas

    Patients with circumstances that will not permit completion of the study or the required follow-up

    Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy

    Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-like Sarcomas

    Protocol: OSU-14056

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, or Ewing/Ewing-like sarcoma of soft tissue or bone. This study will accept the diagnosis made at the investigator's center.
    • WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2.
    • At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease).
    • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF).
    • Subject must be able to swallow and retain oral medication.
    • At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1. Baseline imaging must be performed within 28 days of Day 1 of study.
    • Adequate organ function within 14 days of registration INR (International Normalized Ratio) : patients with no prior evidence of underlying abnormality in coagulation parameters exists, according to the written documentation of the treating physician
    • Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 30% growth of index lesions) within 6 months of registration
    • Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy.

    Exclusion Criteria:

    • Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease.
    • Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib.
    • Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria.
    • Concurrent, clinically significant, active malignancies within 12 months of study enrollment
    • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
    • Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
    • Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy.
    • Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.0 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater.
    • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management.
    • Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization3.2.11
    • Evidence or history of bleeding diathesis or coagulopathy
    • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
    • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
    • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
    • Ongoing infection > Grade 2 NCI-CTCAE v 4.0
    • Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
    • Patients with seizure disorder requiring medication
    • Persistent proteinuria: Grade 3 NCI-CTCAE v 4.0 (> 3.5 g/24 h, measured by urine protein:creatinine ratio on a random urine sample)
    • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
    • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea)
    • History of organ allograft (including corneal transplant).
    • Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial.
    • Any malabsorption condition.
    • Women who are pregnant or breast-feeding.
    • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
    • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
    • Inability to comply with protocol required procedures.
    • Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum]).
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  • open for enrollment

    Hypofractionated Boost before Chemotherapy and Radiation Therapy in Treating Patients with Stage II or III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

    Protocol: OSU-14091

    Eligibility:

    Inclusion Criteria:

    All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment

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

    Hemoglobin >= 9 g/dL

    Platelets >= 100 x 10^9/L

    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5; unless using warfarin for therapeutic anti-coagulation

    Albumin >= 2.5 g/dL

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

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

    Creatinine =< 1.5 ULN AND

    Calculated creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula) or

    24-hour urine creatinine clearance >= 50 mL/min

    Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven

    Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC (T1-4N1-3M0)

    Patients must be considered unresectable or medically-inoperable

    Non-bulky lymphadenopathy =< 3 cm as defined by computed tomography (CT) largest axial diameter

    Patients must have primary tumor =< 6 cm as defined by CT largest axial dimension

    Within 4 weeks of registration: patients must have CT chest with IV contrast, fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-CT scan (or CT abdomen/pelvis), and magnetic resonance imaging (MRI) brain with IV contrast (or CT head with contrast if contraindications to MRI); a non-contrast MRI chest or brain is permitted if patient has allergy to CT contrast or renal insufficiency

    Within 8 weeks of registration: pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO)

    Within 2 weeks of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count panel [CBCP] with differential, chemistries including liver function tests, creatinine clearance [CrCl] assessment, pregnancy test if needed)

    If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded

    Life expectancy of at least 12 weeks in the opinion of investigator

    Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

    Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment

    Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human gonadotropin (HCG) is an acceptable pregnancy assessment

    Nursing women may participate only if nursing is discontinued

    Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment

    Exclusion Criteria:

    Patients with contralateral hilar involvement (greater than 1.5 cm on short axis or positive on PET scan, or biopsy-proven)

    Documented or pathologically-proven metastatic disease

    Presence of nodules considered neoplastic in the same lobe as the primary tumor (stage T3), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost size of 6 cm as defined by CT largest axial dimension

    Presence of nodules considered neoplastic in other ipsilateral lobes (stage T4) or contralateral lobes (M1a)

    Patients with history of pneumonectomy

    Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless > 2 years prior

    Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial

    History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis

    History of previous radiation therapy to the chest which would result in overlapping fields

    History of allergic reaction to cisplatin or etoposide

    Uncontrolled neuropathy grade 2 or greater, regardless of cause

    Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

    Significant pre-existing hearing loss, as defined by the patient or treating physician

    Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as:

    Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)

    Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

    Hepatic insufficiency resulting in jaundice and/or coagulation defects

    Principal Investigator: Terence M Williams, MD, PhD

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  • 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

    Principal Investigator: Lisa D Yee, MD

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  • open for enrollment

    Phase III Comparing Conventional Dose RVD to High-Dose w PSCT in Initial Management of Myeloma

    Protocol: OSU-14069

    Eligibility:

    Inclusion Criteria:

    Participants must have a diagnosis of MM, according to International Myeloma Foundation 2003 Diagnostic Criteria; according to these criteria, the following must be met:

    Monoclonal plasma cells in the bone marrow; 10% (or proven plasmocytic infiltration in bone marrow biopsy) and/or presence of a biopsy-proven plasmacytoma within 35 days of initiation of protocol therapy

    Monoclonal protein (M-protein) present in the serum and/or urine

    Myeloma-related organ dysfunction (1 or more) of the following; a variety of other types of end-organ dysfunctions can occasionally occur and lead to a need for therapy; Note: laboratory assessments used to support the calcium, kidney (renal) failure, anemia, bone lesions (CRAB) criteria in the International Myeloma Foundation (IMF) 2003 Diagnostic Criteria of MM are performed at the time of diagnosis; these assessments are not required to be performed within the 21 days of initiation of protocol therapy

    • [C] Calcium elevation in the blood, defined as serum calcium > 10.5 mg/dl or upper limit of normal
    • [R] Renal insufficiency (defined as serum creatinine above normal)
    • [A] Anemia, defined as hemoglobin < 10 g/dl or 2 g < normal
    • [B] Lytic bone lesions or osteoporosis; if a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining criteria, then; 30% plasma cells are required in the bone marrow or proven plasmocytic infiltration in bone/bone marrow biopsy

    Note: these criteria identify stage IB (if the creatinine is > 2 mg/dl at presentation) and stages II and III A/B myeloma by Durie-Salmon stage; stage IA becomes smoldering or indolent myeloma

    Participants must have documented symptomatic myeloma, with organ damage related to myeloma as defined above with laboratory assessments

    Participants must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains; measurable disease is defined as one or more of the following: serum M-protein >= 1 g/dl (except patients with immunoglobulin [Ig] D or IgA myeloma), urine M-protein >= 200 mg/24 hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl with abnormal serum FLC ratio; for patients with IgD or IgA myeloma, a serum M-protein of greater than or equal to 0.5 g/dl will suffice; free light chain patients not measurable by urine or serum evaluation may be considered for inclusion

    Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

    Negative human immunodeficiency virus (HIV) blood test within 21 days of study entry; HIV-positive individuals on combination antiretroviral therapy are ineligible

    All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS®) program, and be willing and able to comply with the requirements of Revlimid REMS®

    Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 – 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide

    A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)

    Females of childbearing potential must also agree to ongoing pregnancy testing

    Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy

    Ability to understand and the willingness to sign a written informed consent document; voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care

    Exclusion Criteria:

    Participant treated with any prior systemic therapy for myeloma; treatment by localized radiotherapy is not an exclusion criterion if an interval of at least 7 days between the end of radiotherapy and initiation of protocol therapy is observed; intervals of less than 7 days between radiotherapy and initiation of protocol therapy will be considered on a case by case basis with the lead principal investigator (PI), provided toxicity is not a concern; similarly, the dose of corticosteroids received by the participant as part of initial therapy for myeloma should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol therapy

    Primary amyloidosis (AL) or myeloma complicated by amyloidosis

    Participants receiving any other investigational agents

    Participants with known brain metastases should be excluded from this clinical trial

    Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to lenalidomide, bortezomib and/or dexamethasone

    Participants with platelet level < 50,000/mm^3, within 21 days of initiation of protocol therapy for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or platelet count < 30,000/mm^3 for patients in whom >= 50% of bone marrow nucleated cells are plasma cells; transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria

    Participants with an absolute neutrophil count (ANC) < 1000/mm^3, within 21 days of initiation of protocol therapy; growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria

    Participants with hemoglobin level < 8 g/dL, within 21 days of initiation of protocol therapy; transfusion may be used to meet hemoglobin eligibility criteria

    Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible), within 21 days of initiation of protocol therapy

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) >= 2 x institutional ULN, within 21 days of initiation of protocol therapy

    Alkaline phosphatase >= 2 x institutional ULN, within 21 days of initiation of protocol therapy

    Renal insufficiency at the time of screening, defined as serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min (either actual or calculated value may be used), within 21 days of initiation of protocol therapy; creatinine clearance will be the primary eligibility criteria in determining renal insufficiency; the Cockcroft-Gault formula should be used for calculating creatinine clearance values

    Respiratory compromise, defined as ventilation tests with diffusion capacity of the lung for carbon monoxide (DLCO) < 50%

    Participant with clinical signs of heart or coronary failure, or evidence of left ventricular ejection fraction (LVEF) < 40%; participant with myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

    Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements; for patients with a positive hepatitis B antibody result, but no signs of active infection, participating sites must contact the study PI for approval

    Participants with previous history of another malignant condition are excluded, except for localized cancers that have been adequately treated; this includes completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy (e.g. ductal carcinoma in situ [DCIS] of the breast), good risk prostate cancer after curative therapy and/or considered appropriate for watchful waiting (e.g. Gleason 6 or less, T2 or less and prostate-specific antigen [PSA] < 10) , and stage I cervical cancer; if invasive malignancy was experienced 2 or more years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion and approval

    Female participants pregnant or breast-feeding; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lenalidomide; these potential risks may also apply to other agents used in this study; lactating females must agree not to breast feed while taking lenalidomide

    Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration [type Innohep or equivalent])

    Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy

    Principal Investigator: Yvonne A Efebera, MD

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  • open for enrollment

    Surgery With or Without Intraperitoneal Drainage in Improving Complication Rate in Patients With Pancreatic Disease

    Protocol: OSU-11113

    Eligibility:

    Inclusion Criteria:

    The subject has a surgical indication for distal pancreatectomy

    In the opinion of the surgeon, the subject has no medical contraindications to distal pancreatectomy

    The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group

    The subject is willing to comply with 30-day follow-up in the office and answer quality-of-life questionnaires per protocol

    The subject is willing to comply with 90-day follow-up by phone

    Exclusion Criteria:

    Patients who require any type of pancreas resection other than a distal pancreatectomy

    In the opinion of the surgeon, the subject has medical contraindications to distal pancreatectomy

    The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group

    The subject is not willing to comply with 60-day follow-up in the office and answer quality-of-life questionnaires per protocol

    The subject is not willing to comply with 90-day follow-up by phone

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