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Combination Chemotherapy with or without Autologous Stem Cell Transplant in Treating Patients with Central Nervous System B-cell Lymphoma

Trial Status: Closed to Accrual

This 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. Giving chemotherapy before an autologous stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then 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.

Inclusion Criteria

  • 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
  • Karnofsky performance scale >= 30 (>= 50 for patients ages 60-70 years)
  • Patients must be non-pregnant and non-nursing; due to the unknown teratogenic potential of this regimen, 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)
  • Patients must have negative human immunodeficiency virus (HIV) serology
  • Patients must have negative hepatitis C virus (HCV) serology; all patients must be screened for hepatitis B infection before starting treatment; those patients who test positive for hepatitis B should be closely monitored for evidence of active hepatitis B virus (HBV) infection and hepatitis during and for several months after rituximab treatment; PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation
  • Absolute neutrophil count (ANC) >= 1500/mcL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN)
  • Total bilirubin =< 3 mg/dL
  • Creatinine clearance >= 50 mL/min
  • Platelet count >= 100,000/mcL

Exclusion Criteria

  • Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS
  • Patients must have no prior chemotherapy or radiation therapy for lymphoma
  • Patient must have no history of organ transplantation or ongoing immunosuppressant therapy

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Alaska Oncology and Hematology LLC
Status: CLOSED_TO_ACCRUAL
Contact: Keith S. Lanier
Phone: 503-215-2614
Alaska Women's Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Anchorage Associates in Radiation Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Anchorage Oncology Centre
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Anchorage Radiation Therapy Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Katmai Oncology Group
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Providence Alaska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Matthew Joseph Wieduwilt
Phone: 858-822-5354
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mehrdad Abedi
Phone: 916-734-3089
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: James Louis Rubenstein
Phone: 877-827-3222
UCSF Medical Center-Parnassus
Status: CLOSED_TO_ACCRUAL
Contact: James Louis Rubenstein
Phone: 877-827-3222

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Becker
Phone: 203-785-5702

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Peter A.J. Forsyth
Phone: 800-456-7121

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Jonathon B. Cohen
Phone: 404-778-1868

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Meridian
Saint Luke's Cancer Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Nampa
Saint Luke's Cancer Institute - Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth S. Cohen
Phone: 773-834-7424
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: David J. Peace
Phone: 312-355-3046

Indiana

Richmond
Reid Health
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Leyla Shune
Phone: 913-945-7552

Kentucky

Crestview Hills
Oncology Hematology Care Inc-Crestview
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350

Louisiana

New Orleans
Tulane University Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Hana F. Safah
Phone: 504-988-6121

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Lode J. Swinnen
Phone: 410-955-8804

Massachusetts

Boston
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Tracy T. Batchelor
Phone: 877-726-5130
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Tracy T. Batchelor
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Tracy T. Batchelor
Phone: 877-726-5130

Michigan

Battle Creek
Bronson Battle Creek
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Kalamazoo
Borgess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Muskegon
Mercy Health Mercy Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Reed City
Spectrum Health Reed City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Traverse City
Munson Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Wyoming
Metro Health Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Patrick Bruce Johnston
Phone: 855-776-0015

Missouri

Saint Louis
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Nancy L. Bartlett
Phone: 800-600-3606

Nebraska

Omaha
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Philip Jay Bierman
Phone: 402-559-6941

New York

New York
NYP / Weill Cornell Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jia Ruan
Phone: 212-746-1848
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Paul Michael Barr
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Bonnie S. Kiner-Strachan
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Dorothy C. Pan
Phone: 315-464-5476

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Crawford
Phone: 888-275-3853

Ohio

Centerville
Dayton Physicians LLC-Miami Valley South
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Cincinnati
Oncology Hematology Care Inc-Anderson
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Oncology Hematology Care Inc-Blue Ash
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Oncology Hematology Care Inc-Eden Park
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Oncology Hematology Care Inc-Kenwood
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Oncology Hematology Care Inc-Mercy West
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Dayton
Dayton NCI Community Oncology Research Program
Status: ADMINISTRATIVELY_COMPLETE
Contact: Howard M. Gross
Phone: 937-775-1350
Dayton Physician LLC-Miami Valley Hospital North
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital North
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Fairfield
Oncology Hematology Care Inc-Healthplex
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Findlay
Armes Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Blanchard Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Orion Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Dayton Physicians LLC-Atrium
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Greenville
Dayton Physicians LLC-Wayne
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Wayne Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Kettering
Greater Dayton Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Kettering Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Middletown
Dayton Physicians LLC-Signal Point
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Sidney
Dayton Physicians LLC-Wilson
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Springfield
Springfield Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Springfield Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Troy
Dayton Physicians LLC-Upper Valley
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Upper Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350

Oklahoma

Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Joseph P. Lynch
Phone: 918-494-2200
Surgical Associates Inc
Status: CLOSED_TO_ACCRUAL
Contact: Joseph P. Lynch
Phone: 888-823-5923
Warren Clinic Oncology-Tulsa
Status: CLOSED_TO_ACCRUAL
Contact: Joseph P. Lynch
Phone: 888-823-5923

Oregon

Bend
Saint Charles Health System
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Milwaukie
Providence Milwaukie Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Keith S. Lanier
Phone: 503-215-2614
Newberg
Providence Newberg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Oregon City
Providence Willamette Falls Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Portland
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614

Pennsylvania

Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Joseph Joe Lukose Vadakara
Phone: 570-271-5251
Lewistown
Lewistown Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Edward J. Gorak
Phone: 904-202-7051
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Contact: Jan Drappatz
Phone: 412-647-8073

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Adam Louis Cohen
Phone: 801-581-4477

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: CLOSED_TO_ACCRUAL
Contact: Julian R. Sprague
Phone: 802-656-4101
Burlington
University of Vermont Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Julian R. Sprague
Phone: 802-656-4101
University of Vermont and State Agricultural College
Status: CLOSED_TO_ACCRUAL
Contact: Julian R. Sprague
Phone: 802-656-4101

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Beata Holkova
Phone: 804-628-1939

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Anacortes
Cancer Care Center at Island Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Bellevue
Swedish Cancer Institute-Eastside Oncology Hematology
Status: CLOSED_TO_ACCRUAL
Contact: Keith S. Lanier
Phone: 503-215-2614
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Centralia
Providence Regional Cancer System-Centralia
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Edmonds
Swedish Cancer Institute-Edmonds
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Everett
Providence Regional Cancer Partnership
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Issaquah
Swedish Cancer Institute-Issaquah
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Lacey
Providence Regional Cancer System-Lacey
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Longview
PeaceHealth Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Seattle
Fred Hutchinson Cancer Research Center
Status: CLOSED_TO_ACCRUAL
Contact: Frederick R. Appelbaum
Phone: 800-422-6237
Kaiser Permanente Washington
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Minor and James Medical PLLC
Status: CLOSED_TO_ACCRUAL
Contact: Keith S. Lanier
Phone: 503-215-2614
Pacific Gynecology Specialists
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Seattle Cancer Care Alliance
Status: CLOSED_TO_ACCRUAL
Contact: Frederick R. Appelbaum
Phone: 800-422-6237
Swedish Medical Center-Ballard Campus
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Swedish Medical Center-First Hill
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
University of Washington Medical Center - Montlake
Status: CLOSED_TO_ACCRUAL
Contact: Frederick R. Appelbaum
Phone: 800-422-6237
Shelton
Providence Regional Cancer System-Shelton
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Vancouver
Compass Oncology Vancouver
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Keith S. Lanier
Phone: 503-215-2614
Yelm
Providence Regional Cancer System-Yelm
Status: CLOSED_TO_ACCRUAL
Contact: Alison Katherine Conlin
Phone: 503-215-2614

Wisconsin

La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Patrick Bruce Johnston
Phone: 855-776-0015
Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Julie E. Chang
Phone: 877-405-6866

PRIMARY OBJECTIVE:

I. To compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of high-dose therapy (HDT)/autologous stem cell transplant (ASCT) versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide.

SECONDARY OBJECTIVES:

I. To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine.

II. To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine.

III. To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine.

IV. To determine diffusion magnetic resonance imaging (MRI) metrics (apparent diffusion coefficient [ADC]mini, ADC25%, and ADCmean) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (Cancer and Leukemia Group B [CALGB] 581101).

V. To determine brain fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) metrics (tumor standardized uptake value [SUV] and tumor versus background SUV) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101).

VI. To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101).

VII. To determine whether reduction in SUV by > 25% on brain FDG-PET/computed tomography (CT) after one cycle of induction therapy is associated with improved PFS and OS (CALGB 581101).

VIII. To determine which immunohistochemistry (IHC)-based biomarkers are predictive of an adverse prognosis (CALGB 151113).

IX. To determine which IHC-based biomarkers are predictive of a favorable prognosis (CALGB 151113) for BCL6 (B-cell CLL/lymphoma 6), and STAT 6 (signal transducer and activator of transcription 6, interleukin-4 induced).

X. To analyze tumor tissue for gene mutational analysis via whole exome sequencing, copy number aberrations, and expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113).

XI. To determine whether cerebrospinal fluid (CSF) proteome is a predictor of outcomes (prognostic marker) irrespective of treatment arm (CALGB 151113) for (IL-10 [interleukin-10] and C3 [complement component 3]).

XII. To assess the neurocognitive function of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy (etoposide and cytarabine) as measured by serial administration of the International Primary Central Nervous System Lymphoma (PCNSL) Collaborative Group (IPCG) neurocognitive battery and evaluate the long-term survivorship differences between the two arms (CALGB 71105).

XIII. To assess the quality of life of patients treated with consolidation HDT/ASCT versus those treated with consolidation etoposide and cytarabine as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTC-QLQ30/BCM20), and to evaluate the long-term survivorship differences between the two arms (CALGB 71105).

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive methotrexate intravenously (IV) over 4 hours on days 1 and 15 (cycles 1-4); leucovorin IV every 6 hours beginning 24 hours after each methotrexate dose (cycles 1-4); rituximab IV on days 3, 10, 17, and 24 (cycle 1), and days 3 and 10 (cycle 2); temozolomide orally (PO) on days 7-11 (cycles 1-4); and cytarabine IV over 2 hours twice daily (BID) on days 1 and 2 (cycle 5 only). Treatment repeats every 28 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response, complete response unconfirmed, partial response, or stable disease proceed to consolidation therapy.

CONSOLIDATION THERAPY: Patients are randomized to 1 of 2 arms.

ARM I: Between 3-5 weeks after induction therapy patients undergo stem cell mobilization per participating institution guidelines.

CONSOLIDATION THERAPY: Beginning 2-4 weeks after stem cell mobilization, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 and thiotepa IV over 2 hours every 12 hours on days -5 to -4. Beginning on day 4, patients also receive filgrastim subcutaneously (SC) once a day and continuing until absolute neutrophil count recovers.

STEM CELL RESCUE: Patients then undergo autologous peripheral blood stem cell transplantation (PBSCT) on day 0.

ARM II: Beginning no earlier than 4 weeks and no later than 12 weeks after day 1 of cycle 5 of induction therapy, patients receive cytarabine IV over 2 hours every 12 hours on days 1-4, and etoposide IV continuously over 96 hours on days 1-4. Beginning on day 4, patients also receive filgrastim SC once a day and continuing until absolute neutrophil count recovers.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Tracy T. Batchelor

  • Primary ID CALGB-51101
  • Secondary IDs NCI-2012-00110, CDR0000721927
  • Clinicaltrials.gov ID NCT01511562