Overview

Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2001-03-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Colony-stimulating factors may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkin's lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Nebraska
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cytarabine
Etoposide
Lenograstim
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Diagnosis of non-Hodgkin's lymphoma (NHL) Relapsed disease OR
Refractory to first line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)
chemotherapy No myelodysplastic syndrome or chronic myeloid leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 150,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective barrier contraception No other prior
malignancy except: Curatively treated basal cell or squamous cell carcinoma Carcinoma in
situ of the cervix Surgically cured malignancy No hypersensitivity to E. coli derived
products (e.g., filgrastim (G-CSF), insulin, asparaginase)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem
cell (PBSC) transplantation for NHL No prior filgrastim-SD/01 No other concurrent
myelopoietic growth factors No concurrent WBC transfusions No concurrent PBSC collection
Chemotherapy: See Disease Characteristics No more than 2 prior courses of chemotherapy for
any malignancy Endocrine therapy: No concurrent corticosteroids except topical steroids or
as premedications or associated with chemotherapy Radiotherapy: At least 4 weeks since
prior radiotherapy Surgery: Not specified Other: At least 72 hours since prior
antimicrobials At least 30 days since other prior investigational drug No other concurrent
investigational drug No concurrent prophylactic antibiotics during course 1