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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

    Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer Who Received Chemotherapy

    Protocol: OSU-13194

    Eligibility:

    Inclusion Criteria:

    Women who have been diagnosed with stage I-IIIA breast cancer will be recruited 1-8 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors); recruit women who have received one of the two most common stage I-IIIA chemotherapy regimens, either docetaxel/cyclophosphamide or doxorubicin/cyclophosphamide followed by paclitaxel to provide uniformity of prior treatment

    All women will be postmenopausal, defined as having follicle-stimulating hormone (FSH) and estradiol within the institutional postmenopausal range at the time of study entry and no menstrual cycle in the last 12 months

    Exclusion Criteria:

    A prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)

    Anemia (defined as having a hemoglobin level less than 11.7 g/dL for white women, following the Ohio State University (OSU) hospital’s criteria, and 11.5 for African American women, based on data from Beutler and Waalen)

    Alcohol or drug abuse

    Smoking

    Individuals who routinely take fish oil, krill oil, or flaxseed (oil, pills, or powder) or consume more than two portions of oily fish per week

    Women with blood pressures above 180/100 or below 80/50

    Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions

    Antidepressant users who have been medicated for at least three months will not be excluded

    Women who have received typhoid vaccine within three years or any other vaccine within three months will be excluded

    Principal Investigator: Janice K Kiecolt-Glaser, PhD

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  • open for enrollment

    Biobehavioral Intervention in Reducing Stress and Improving Quality of Life in Patients With Newly Diagnosed Stage I-III Breast Cancer

    Protocol: OSU-13127

    Eligibility:

    Inclusion Criteria:

    Newly diagnosed and surgically treated females with stage I-III breast cancer

    Able to speak/read English

    Able to give informed consent

    Exclusion Criteria:

    Non-ambulatory

    Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit

    Major mental illness (e.g., schizophrenia, psychotic disorder)

    Principal Investigator: Barbara L Andersen, PhD

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  • open for enrollment

    Carboplatin in Treating Patients with Recurrent High-Grade Gliomas

    Protocol: OSU-10151

    Eligibility:

    Inclusion Criteria:

    All patients must have progressive disease for which craniotomy and tumor resection is recommended as treatment

    All patients must sign a consent form indicating that they are aware of the investigational nature of the study; the informed consent form will indicate that the patient has been made aware of all other appropriate therapies

    Patients with histologically confirmed grade III or IV astrocytoma, oligoastrocytoma, and oligodendroglioma who are at first or second recurrence

    All patients require an initial diagnosis of a malignant glioma as outlined in the inclusion criteria which must be confirmed at the treating facility

    Patients must have unequivocal evidence of tumor progression by magnetic resonance imaging (MRI) performed no longer than 28 days prior to study registration

    Patients must have pathologically confirmed recurrence at the time of catheter placement

    Patients must be on a stable or decreasing dexamethasone dosage for at least 1 week prior to baseline MRI

    Patients must have been treated previously with radiation therapy and treatment must have been completed at least 8 weeks prior to surgery for catheter implantation

    Last dose of cytotoxic chemotherapy must have been at least 4 weeks (6 weeks for nitrosoureas) prior to catheter placement; patients are eligible if they received bevacizumab or other anti-vascular endothelial growth factor (VEGF) therapies, although the most recent dose must be at least 6 weeks prior to catheter placement

    Patients previously treated with stereotactic radiosurgery, stereotactic radiotherapy, brachytherapy, Gliadel wafers or other intratumoral chemotherapy are eligible

    Patients must have recovered from all prior therapy

    Patients must have a life expectancy of >= 3 months and a Karnofsky performance status >= 60

    Leukocytes >= 3,000/mcL

    Absolute neutrophil count >= 1,500/mcL

    Platelets >= 100,000/mcL

    Hemoglobin >= 9 g/dL

    Serum calcium =< 12.0 mg/dL

    Total serum bilirubin < institutional upper limit of normal (ULN)

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN

    Creatinine < 1.5 X institutional ULN

    Women of child bearing years must have a negative pregnancy test (serum or urine) within 1 week of study entry; men and women of reproductive potential must agree to use an effective contraceptive method including one of the following: surgical sterilization (tubal ligation for women or vasectomy for men); approved hormonal contraceptives (such as birth control pills, Depo-Provera or Lupron Depro); barrier methods (such as condom or diaphragm) used with a spermicide cream or an intrauterine device (IUD)

    Patient or designated individuals with durable medical power of attorney must give written informed consent prior to any study-specific procedures being implemented

    Both men and women and members of all races and ethnic groups are eligible for this trial

    Exclusion Criteria:

    Patients with infratentorial, multifocal, or pathologically confirmed cerebrospinal fluid (CSF) disseminated tumor

    Patients that have been treated with > 3 prior chemotherapy regimens

    Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

    Patients who have a history of bleeding disorders including congenital or acquired coagulopathies

    Known acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition or other acquired or congenital disorder of the immune system

    Patients with unstable or serious concurrent illness including, but not limited to, ongoing or active infections requiring IV antibiotics or psychiatric illness/social situations that would limit compliance with study requirements are ineligible; (if patient has a stable chronic infection requiring oral antibiotics, the patient may be treated at the investigators discretion; however a clinical note must include the justification regarding the safety of treating the patient)

    Patients who have received any other investigational agent in a 28-day period prior to enrollment in this study

    Patients whose tumors are located less than 2 cm from the ventricles

    Patients taking greater than 12 mg daily of dexamethasone

    Prior invasive malignancy that is not low-grade glioma, glioblastoma or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years

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  • open for enrollment

    MRI Before and During Surgery in Diagnosing Patients With Bladder Cancer

    Protocol: OSU-08063

    Eligibility:

    Inclusion Criteria:

    Patient with known bladder cancer

    Patient is scheduled for radical cystectomy and lymph node dissection

    Patient is able and willing to give valid written informed consent

    Patient has no contraindications to the MRI

    Exclusion Criteria:

    Women who are pregnant or planning to become pregnant during the trial

    Women who are breastfeeding

    Patient with allergy to contrast agent

    Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate (eGRF) less than 30 mL/min/1.73m^2

    Any condition conflict based on the investigation’s clinical judgment that would prevent the patient from completion all trial assessments and visits

    Inability or unwillingness to cooperate with requirements of this trial

    Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR

    Patients with sickle cell anemia and other hemolytic anemia

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    The Role of Direct Visual Fluorescence in Oral Examination

    Protocol: OSU-08095

    Eligibility:

    Inclusion Criteria:

    HIGH-RISK POPULATION:

    33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate

    GENERAL POPULATION:

    250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate

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  • open for enrollment

    Ph 3 Post-Mast CW & RXRT & Post-Lump RXRT in PA Nodes before NCT who Convert to PNA Nodes after NCT

    Protocol: RTOG-1304

    Eligibility:

    Inclusion Criteria:

    The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines

    The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan

    Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted

    Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing

    Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible

    Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen

    For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: it is preferred that all intended chemotherapy be administered in the neoadjuvant setting

    Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated

    At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:

    Axillary node dissection

    Sentinel node biopsy alone provided that at least 2 sentinel lymph nodes are removed; removal of at least 3 sentinel lymph nodes and use of dual tracer for lymphatic mapping are strongly recommended or

    Sentinel node biopsy followed by axillary node dissection

    Note: patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an National Cancer Institute (NCI) Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study

    Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible

    Patient who have undergone either a total mastectomy or a lumpectomy are eligible; (patients who have had a nipple-sparing mastectomy are eligible)

    For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)

    For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor

    The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days

    The patient must have recovered from surgery with the incision completely healed and no signs of infection

    If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved

    Exclusion Criteria:

    Definitive clinical or radiologic evidence of metastatic disease

    T4 tumors including inflammatory breast cancer

    Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone

    N2 or N3 disease detected clinically or by imaging

    Patients with histologically positive axillary nodes post neoadjuvant therapy

    Patients with microscopic positive margins after definitive surgery

    Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)

    Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)

    History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization

    Any radiation therapy for the currently diagnosed breast cancer prior to randomization

    Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization

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

    Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma

    Pregnancy or lactation at the time of study entry; (Note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)

    Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up

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

    Principal Investigator: Julia White, MD

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  • open for enrollment

    Sorafenib Tosylate with or without Stereotactic Body Radiation Therapy in Treating Patients with Liver Cancer

    Protocol: RTOG-1112

    Eligibility:

    Inclusion Criteria:

    Patients must have an HCC diagnosis (initial, recurrent, progressive and/or refractory to other therapies) by at least one criterion listed below =< 360 days prior to study entry

    Pathologically (histologically or cytologically) proven diagnosis of HCC

    At least one solid liver lesion or vascular tumor thrombosis (involving portal vein, inferior vena cava [IVC] and/or hepatic vein) > 1 cm with arterial enhancement and delayed washout on multi-phasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis

    For patients whose CURRENT disease is vascular only: enhancing vascular thrombosis (involving portal vein, IVC and/or hepatic vein) demonstrating early arterial enhancement and delayed washout on multi-phasic CT or MRI, in a patient with known HCC (diagnosed previously < 720 days)

    Measureable hepatic disease and/or presence of vascular tumor thrombosis (involving portal vein, IVC and/or hepatic vein) which may not be measureable as per Response Evaluation Criteria in Solid Tumors (RECIST) on liver CT or MRI, within 28 days of registration

    Appropriate for protocol entry based upon the following minimum diagnostic workup:

    History/physical examination including examination for encephalopathy, ascites, weight, height, and blood pressure within 14 days prior to study entry

    Assessment by radiation oncologist and medical oncologist or hepatologist who specializes in treatment of HCC within 28 days prior to study entry

    Pre-randomization scan (REQUIRED for all patients): CT scan chest/abdomen/pelvis with multiphasic liver CT or multiphasic liver magnetic resonance (MR) scan within 28 days prior to study entry; MRI of abdomen with contrast and pelvis is permitted

    Zubrod performance status 0-2 within 28 days prior to study entry

    Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

    Platelets >= 70,000 cells/mm^3

    Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

    Total bilirubin < 2 mg/dL

    Internationalized normal ratio (INR) < 1.7

    Albumin >= 28 g/L

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 6 times upper limit of normal (ULN)

    Serum creatinine =< 1.5 x ULN or creatinine clearance >= 60 mL/min

    Barcelona Clinic Liver Cancer (BCLC) stage: intermediate (B) or advanced (C) within 14 days prior to study entry

    Child-Pugh score A within 14 days prior to study entry

    Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of radiation therapy (RT) and for at least 28 days following the last dose of sorafenib (whichever is later)

    Unsuitable for resection or transplant or radiofrequency ablation (RFA)

    Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) or drug eluting beads (DEB) for any of the following reasons, as described by Raoul et al (2011):

    Technical contraindications: arteriovenous fistula, including surgical portosystemic shunt or spontaneous portosystemic shunt

    Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion

    Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease

    Presence of extrahepatic disease

    No response post TACE (or DEB) or progressive HCC despite TACE; prior TACE or DEB is allowed but must be > 28 days from study entry

    Serious toxicity following prior TACE (or DEB); prior TACE or DEB must be > 28 days from study entry

    Other medical comorbidities making TACE (or DEB) unsafe and/or risky (e.g. combination of relative contraindications including age > 80 years, tumor > 10 cm, > 50% replacement of the liver by HCC, extensive multinodular bilobar HCC, biliary drainage)

    Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria

    Patient must be able to provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

    Prior sorafenib use > 60 days; note that prior chemotherapy for HCC or a different cancer is allowable

    Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields

    Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months before registration

    Transmural myocardial infarction within the last 6 months prior to study entry

    Unstable ventricular arrhythmia within the last 6 months prior to study entry

    Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry

    Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 60 days prior to study entry

    Bleeding within 60 days prior to study entry due to any cause, requiring transfusion

    Thrombolytic therapy within 28 days prior to study entry; subcutaneous heparin is permitted

    Known bleeding or clotting disorder

    Uncontrolled psychotic disorder

    Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

    Any one hepatocellular carcinoma > 15 cm

    Total maximal sum of hepatocellular carcinomas or a single conglomerate HCC > 20 cm

    More than 5 discrete intrahepatic parenchymal foci of HCC

    Direct tumor extension into the stomach, duodenum, small bowel or large bowel

    Measureable common or main branch biliary duct involvement with HCC

    Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm

    Use of regular phenytoin, carbamazepine, hypericum perforatum (also known as St. John's wort) or rifampin

    Use of combination anti-retroviral therapy for human immunodeficiency virus (HIV)

    Prior liver transplant

    Principal Investigator: Terence M Williams, MD, PhD

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  • open for enrollment

    Light Sedation or Intubated General Anesthesia in Reducing Complications and Length of Hospital Stay in Patients With Brain Cancer Undergoing Craniotomy

    Protocol: OSU-12161

    Eligibility:

    Inclusion Criteria:

    Non-pregnant females

    Elective craniotomy for supratentorial brain tumors

    Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain)

    First craniotomy

    American Society of Anesthesiologists (ASA) I-III

    Body mass index (BMI) < 35

    Exclusion Criteria:

    Posterior fossa tumor/approach for tumor resection requiring the prone position

    Traumatic lesions/hematomas

    Emergency case

    Systemic disease burden with metastatic tumor to the brain

    Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay

    Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas

    Prisoners

    Pregnant women

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  • open for enrollment

    Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

    Protocol: OSU-12241

    Eligibility:

    Inclusion criteria : I 01. Males or females enrolled in Phase 1 or Phase 2 studies of SAR245408 or SAR245409 as monotherapy or in combination with other regimens who have complete data collection for the primary endpoint(s) of the parental study or who are being treated beyond the parental study cut-off and meet all the criteria to continue to be treated per the parental protocol. I 02. All sexually active subjects (male and female) must agree to continue to use accepted methods of barrier contraception (ie, condoms) during the course of the study and for 3 months after discontinuation of study treatment. For women of childbearing potential and for men who can father a child, a second method of contraception in addition to a barrier method is recommended. Hormonal contraception should be avoided in subjects taking SAR245408 due to possible drug-drug interaction. I 03. Female subjects of childbearing potential must have a negative pregnancy test at baseline. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression Exclusion criteria: E 01. The subject discontinued the parental study due to toxicity E 02. Ongoing Grade 3 or higher Adverse Event (AE) E 03. Ongoing Serious Adverse Event (SAE) E 04. Subjects with ongoing dose interruption for any reason unless the subject fulfills the criteria in the parental protocol for restarting IMP. In such case subject will start the treatment-extension study on Day 1 of the initiation period E 05. The subject has any of the following laboratory values ≥ Common Terminology of Adverse Events (CTCAE) Grade 3 - Absolute neutrophil count (ANC), - Platelet count, - Hemoglobin, - Bilirubin, - Serum creatinine or calculated creatinine clearance, - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), - Fasting plasma glucose (FPG), - Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) E 06. The subject has a baseline corrected QT interval (QTc) >481 msec or if a subject has had a QTc interval increase of ≥ 60 msec from parental protocol baseline to an absolute value of > 470 msec E 07. The subject has a known allergy or hypersensitivity to components of the study treatment formulation(s) E 08. The subject is pregnant or breastfeeding The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

    Principal Investigator: David E Cohn, MD

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  • open for enrollment

    Phase 3, Randomized Trial of RIC & Transplantation of dUCB vs Haplo for Patients w Hem Malignancies

    Protocol: BMT-CTN1101

    Eligibility:

    Inclusion Criteria:

    Patients 18 to 70 years old

    Patients must have available both: a)One or more potential related mismatched donors

    (biologic parent(s) or siblings (full or half) or children). At least low resolution

    DNA based human leukocyte antigen (HLA) typing at HLA-A, -B, and -DRB1 for potential

    haploidentical sibling donors is required. b)At least two potential umbilical cord

    blood units identified. Each unit must have a minimum of 1.5 x 10^7/kg

    pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units,

    the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least

    2.0 x 10^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at

    HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high

    resolution using DNA based typing). Confirmatory typing is not required for

    randomization.

    Acute Lymphoblastic Leukemia (ALL) in first complete remission (CR1) that is NOT

    considered favorable-risk as defined by the presence of at least one of the

    following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), other Mixed

    Lineage Leukemia (MLL) rearrangements; White blood cell counts of greater than

    30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL)at diagnosis; Recipient age

    older than 30 years at diagnosis; Time to CR greater than 4 weeks

    Acute Myelogeneous Leukemia (AML) in CR1 that is NOT considered as favorable-risk.

    Favorable risk is defined as having one of the following: t(8.21) without CKIT

    mutation, inv(16) without CKIT mutation or t(16;16), normal karyotype with mutated

    NPM1 and not FLT-IND, normal karyotype with double mutated CEBPA, Acute promyelocytic

    leukemia (APL) in first molecular remission at end of consolidation

    Acute Leukemias in 2nd or subsequent CR

    Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR,

    adult T-cell leukemia/lymphoma in first or subsequent CR

    Burkitt's lymphoma: second or subsequent CR

    Lymphoma fulfilling the following criteria: Chemotherapy-sensitive (at least stable

    disease lymphomas that have failed at least 1 prior regimen of multi-agent

    chemotherapy and are INELIGIBLE for an autologous transplant. Patients with chronic

    lymphocytic leukemia (CLL) are not eligible regardless of disease status.

    Performance status: Karnofsky score greater than or equal to 70%.

    Additional Patient Inclusion Criteria for Conditioning:

    Patients with Adequate Physical Function as Measured by: a. Cardiac: Left ventricular

    ejection fraction at rest must be greater than or equal to 40%, or shortening

    fraction less than 25%; b. Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except

    for patients with Gilbert's syndrome or hemolysis. Alanine aminotransferase (ALT),

    aspartate aminotransferase (AST), and Alkaline Phosphatase less than 5 x upper limit

    of normal; c. Renal: Serum creatinine within normal range, or if serum creatinine

    outside normal range, then renal function (measured or estimated creatinine clearance

    or GFR)greater than 40 mL/min/1.73m^; d. Pulmonary: Diffusing capacity of the lung

    for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in

    one second (FEV1), and forced vital capacity (FVC) greater than 50% predicted;

    Additional Patient Inclusion Criteria for Patients Assigned to Haploidentical BM Arm:

    Patients must be HLA typed at high resolution using DNA based typing at the following

    HLA-loci: HLA-A, -B, -C and DRB1 and have available a related haploidentical BM donor

    with 2, 3, or 4 HLA-mismatches. A unidirectional mismatch in either the graft versus

    host or host versus graft direction is considered a mismatch. The donor and recipient

    must be HLA identical for at least one antigen (using high resolution DNA based

    typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. Fulfillment

    of this criterion shall be considered sufficient evidence that the donor and

    recipient share one HLA haplotype, and typing of additional family members is not

    required.

    Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord

    Blood Arm:

    1. Patients must have available two UCB units fulfilling the following criteria:

    1. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total

    nucleated cell dose. For non-red blood cell depleted units, the minimum

    pre-cryopreserved total nucleated cell dose of each unit must be at least

    2.0 x10^7/kg.

    2. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA -A,

    HLA-B (at low resolution using DNA based typing), and HLA -DRB1 (at high

    resolution using DNA based typing).

    3. Additional graft selection criteria specified in section 2.5

    2. Patients must have received at least one cycle of the cytotoxic chemotherapy

    regimens (or regimen of similar intensity) listed in Appendix D within 3 months

    of enrollment (measured from the start date of chemotherapy) OR have had an

    autologous transplant within 24 months of enrollment OR receive 300 cGy as part

    of the preparative regimen

    Exclusion Criteria:

    Patients with suitably matched related or unrelated donor, as defined per

    institutional practice.

    Recipients of prior autologous hematopoietic stem cell transplantation are ineligible

    if disease recurrence occurred less than 6 months from their autologous stem cell

    transplant.

    Current uncontrolled bacterial, viral or fungal infection (currently taking

    medication with evidence of progression of clinical symptoms or radiologic findings).

    Prior allogeneic HCT.

    Patients with history of primary idiopathic myelofibrosis or any severe marrow

    fibrosis.

    Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.

    Anti-donor HLA antibodies.

    Additional exclusion criteria:

    Pregnancy or breast-feeding.

    Evidence of HIV infection or known HIV positive serology.

    Principal Investigator: Sumithira Vasu, MD

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