PHASE II STUDY OF HIGH-DOSE CYCLOPHOSPHAMIDE PLUS RECOMBINANT HUMAN GRANULOCYTE-COLONY STIMULATING FACTOR (rhG-CSF) IN THE TREATMENT OF FOLLICULAR LOW-GRADE NON-HODGKIN'S LYMPHOMA
OBJECTIVES: I. Determine the feasibility of high-dose cyclophosphamide and filgrastim
(G-CSF) in patients with stage IV, relapsed, or progressive low-grade follicular
non-Hodgkin's lymphoma. II. Determine the toxic effects of this regimen in these patients,
including those with marrow involvement. III. Determine the rates of complete remission (CR)
and partial remission and time to failure in previously treated and untreated patients. IV.
Determine the effectiveness of this regimen in eradicating bcl-2 rearrangements, as
determined by polymerase chain reaction (PCR), in previously untreated patients. V.
Correlate the duration of CR to PCR results in responding patients.
OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients receive
cyclophosphamide IV over 90 minutes on day 1 and filgrastim (G-CSF) subcutaneously beginning
on day 3 and continuing until blood counts recover. Treatment continues every 2 weeks for 4
courses in the absence of disease progression or stable disease. Patients who achieve
complete remission (CR) after completion of course 4 receive 2 additional courses. Patients
who achieve partial remission (PR) after completion of course 4 receive 2 additional
courses, and those who achieve CR after completion of course 6 receive 2 additional courses.
Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Robert T. Perri, MD
Veterans Affairs Medical Center - Minneapolis
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|University of Massachusetts Memorial Medical Center||Worcester, Massachusetts 01655|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center||Winston-Salem, North Carolina 27157-1082|
|Rhode Island Hospital||Providence, Rhode Island 02903|
|CCOP - Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|Ellis Fischel Cancer Center - Columbia||Columbia, Missouri 65203|
|Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|University of Tennessee, Memphis Cancer Center||Memphis, Tennessee 38103|
|Mount Sinai Medical Center, NY||New York, New York 10029|