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