Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

Description

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.

Study Start Date

September 2012

Estimated Completion Date

October 2026

Interventions

  • Drug: etoposide
  • Drug: thiotepa
  • Drug: carmustine
  • Procedure: autologous hematopoietic stem cell transplantation
  • Procedure: stem cell transplant
  • Drug: G-CSF
  • Procedure: filgrastim
  • Drug: cytarabine
  • Procedure: transplant
  • Procedure: peripheral blood stem cell transplantation

Specialties

  • Neurology: Neurologic Oncology
  • Oncology: BMT/SCT,Leukemia/Lymphoma,Neurologic Oncology,Pharmacology/Therapy
  • Allergy/Immunology: Hematology/Oncology,Vaccine/Immunotherapy
  • Pharmacy: Chemotherapy/Oncology

MeSH Terms

  • Central Nervous System Neoplasms
  • Hematopoietic Stem Cell Transplantation
  • Lymphoma, B-Cell
  • Peripheral Blood Stem Cell Transplantation

Study ID

National Cancer Institute (NCI) -- CDR0000721927

Status

Recruiting

Trial ID

NCT01511562

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

160

Sponsor

National Cancer Institute (NCI)

DISEASE CHARACTERISTICS:
  • Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following:
  • Brain biopsy or resection
  • Cerebrospinal fluid
  • Vitreous fluid
  • No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS
  • No isolated ocular lymphoma or isolated leptomeningeal lymphoma
  • At least one measurable, contrast-enhancing brain lesion (? 1 cm in length) PATIENT CHARACTERISTICS:
  • Karnofsky performance status ? 30% (? 50% for patients ages 60-70 years)
  • Adequate cardiac function (left ventricular ejection fraction [LVEF] ? 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ? 60% predicted)
  • Pregnant or nursing patients may not be enrolled
  • women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
  • Negative human immunodeficiency virus (HIV) serology
  • Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative)
  • Absolute neutrophil count (ANC) ? 1500/mcL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2 times upper limit of normal (ULN)
  • Total bilirubin ? 3 mg/dL
  • Creatinine clearance ? 50 mL/min
  • Platelet count ? 100,000/mcL PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or radiation therapy for lymphoma
  • No history of organ transplantation or ongoing immunosuppressant therapy
  • No concurrent palliative radiotherapy
  • Gender

    Both

    Ages

    18 Years to 70 Years

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (57)

    Study Location Distance Name Phone Email
    DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles Tracy Batchelor MD MPH 617-643-1938 None
    Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Tracy Batchelor MD 617-643-1938 None
    Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Tracy Batchelor MD 617-643-1938 None
    Stony Brook University Medical Center - Stony Brook, New York 145.7 miles Bonnie KinerStrachan MD 631-444-2316 None
    State University of New York Upstate Medical University - Syracuse, New York 259.8 miles Thomas Coyle MD 315-464-4353 None
    Geisinger Medical Center - Danville, Pennsylvania 301.1 miles Edward Gorak MD 570-571-6045 None
    University of Rochester - Rochester, New York 335.8 miles Jonathan Friedberg MD 585-275-4911 None
    Johns Hopkins UniversitySidney Kimmel Cancer Center - Baltimore, Maryland 356.0 miles Lode Swinnen MD 410-614-6398 None
    University of Pittsburgh Cancer Institute UPCI - Pittsburgh, Pennsylvania 477.2 miles Jan Drappatz MD 412-648-6507 None
    Duke University Medical Center - Durham, North Carolina 609.0 miles Jeffrey Crawford MD 919-681-9509 None
    Blanchard Valley Hospital - Findlay, Ohio 654.4 miles Howard Gross MD 937-832-1093 None
    Upper Valley Medical Center - Troy, Ohio 701.0 miles Howard Gross MD 937-832-1093 None
    Dayton NCI Community Oncology Research Program - Dayton, Ohio 704.2 miles Howard Gross MD 937-832-1093 None
    Kettering Medical Center - Kettering, Ohio 705.8 miles Howard Gross MD 937-832-1093 None
    Miami Valley Hospital - Dayton, Ohio 706.7 miles Howard Gross MD 937-832-1093 None
    Samaritan North Health Center - Dayton, Ohio 709.0 miles Howard Gross MD 937-832-1093 None
    Good Samaritan Hospital Dayton - Dayton, Ohio 709.4 miles Howard Gross MD 937-832-1093 None
    Atrium Medical CenterMiddletown Regional Hospital - Franklin, Ohio 716.9 miles Howard Gross MD 937-832-1093 None
    Bronson Battle Creek - Battle Creek, Michigan 719.8 miles Gilbert Padula MD 616-752-6218 None
    Wayne Hospital - Greenville, Ohio 721.3 miles Howard Gross MD 937-832-1093 None
    Oncology Hematology Care IncBlue Ash - Cincinnati, Ohio 726.5 miles Howard Gross MD 937-832-1093 None
    Oncology Hematology Care IncKenwood - Cincinnati, Ohio 730.0 miles Howard Gross MD 937-832-1093 None
    Oncology Hematology Care IncAnderson - Cincinnati, Ohio 732.6 miles Howard Gross MD 937-832-1093 None
    Borgess Medical Center - Kalamazoo, Michigan 734.7 miles Sunil Nagpal MD 269-382-2500 None
    Oncology Hematology Care IncHealthplex - Fairfield, Ohio 734.9 miles Howard Gross MD 937-832-1093 None
    Spectrum Health Reed City Hospital - Reed City, Michigan 735.0 miles Gilbert Padula MD 616-752-6218 None
    Oncology Hematology Care IncEden Park - Cincinnati, Ohio 737.7 miles Howard Gross MD 937-832-1093 None
    Reid Hospital and Health Care Services - Richmond, Indiana 739.9 miles Howard Gross MD 937-832-1093 None
    Oncology Hematology Care IncMercy West - Cincinnati, Ohio 740.9 miles Howard Gross MD 937-832-1093 None
    Spectrum Health at Butterworth Campus - Grand Rapids, Michigan 741.6 miles Gilbert Padula MD 616-752-6218 None
    Mercy Health Saint Marys - Grand Rapids, Michigan 741.6 miles Gilbert Padula MD 616-752-6218 None
    Bronson Methodist Hospital - Kalamazoo, Michigan 741.8 miles Sunil Nagpal MD 269-382-2500 None
    Oncology Hematology Care IncCrestview - Crestview Hills, Kentucky 742.9 miles Howard Gross MD 937-832-1093 None
    Munson Medical Center - Traverse City, Michigan 750.3 miles Gilbert Padula MD 616-752-6218 None
    Mercy Health Mercy Campus - Muskegon, Michigan 767.9 miles Gilbert Padula MD 616-752-6218 None
    Lakeland Community Hospital - Niles, Michigan 778.9 miles Gilbert Padula MD 616-752-6218 None
    Lakeland Hospital - Saint Joseph, Michigan 787.9 miles Gilbert Padula MD 616-752-6218 None
    Marie Yeager Cancer Center - Saint Joseph, Michigan 787.9 miles Gilbert Padula MD 616-752-6218 None
    University of Chicago Comprehensive Cancer Center - Chicago, Illinois 848.0 miles Chadi Nabhan MD 773-702-9574 None
    University of Illinois - Chicago, Illinois 851.3 miles David Peace MD 312-413-1507 None
    Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Nina WagnerJohnston MD 314-362-5654 None
    Mayo Clinic - Rochester, Minnesota 1,083.1 miles Patrick Johnston MD 507-284-5362 None
    University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Philip Bierman MD 402-559-5520 None
    Huntsman Cancer InstituteUniversity of Utah - Salt Lake City, Utah 2,094.1 miles Adam Cohen MD 801-585-0255 None
    University of Washington Medical Center - Seattle, Washington 2,487.7 miles Maciej M Mrugala MD 206-598-9487 None
    Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Maciej M Mrugala 206-667-4692 None
    PeaceHealth Southwest Medical Center - Vancouver, Washington 2,530.3 miles Alison Conlin MD 503-216-6300 None
    Clackamas Radiation Oncology Center - Clackamas, Oregon 2,531.8 miles Alison Conlin MD 503-216-6300 None
    Western Oncology Research Consortium - Portland, Oregon 2,533.3 miles Alison Conlin MD 503-216-6300 None
    Providence Portland Medical Center - Portland, Oregon 2,533.3 miles Alison Conlin MD 503-216-6300 None
    Providence Willamette Falls Medical Center - Oregon City, Oregon 2,534.7 miles Alison Conlin MD 503-216-6300 None
    Providence Milwaukie Hospital - Milwaukie, Oregon 2,535.6 miles Alison Conlin MD 503-216-6300 None
    Saint John Medical Center - Longview, Washington 2,541.2 miles Alison Conlin MD 503-216-6300 None
    Providence Saint Vincent Medical Center - Portland, Oregon 2,542.0 miles Alison Conlin MD 503-216-6300 None
    Providence Newberg Medical Center - Newberg, Oregon 2,554.8 miles Alison Conlin MD 503-216-6300 None
    University of California Davis Comprehensive Cancer Center - Sacramento, California 2,628.4 miles Mehrdad Abedi MD 916-734-3771 None
    UCSF Medical CenterMount Zion - San Francisco, California 2,698.0 miles James Rubenstein MD 415-502-4430 None

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