Non Hodgkin Lymphoma Clinical Trial
Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin’s Lymphoma
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.
Full Description
OBJECTIVES: I. Compare the effect of single dose filgrastim-SD/01 vs daily filgrastim (G-CSF) on the duration of neutropenia in course 1 after combination chemotherapy in patients with recurrent non-Hodgkin's lymphoma. II. Compare the effect of these regimens on duration of neutropenia in courses 2-4, absolute neutrophil counts (ANC) in courses 1-4, time to ANC recovery in courses 1-4, and safety in these patients. III. Determine the pharmacokinetic profile of these drugs in course 1 in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. All patients receive etoposide IV over 1 hour on days 1-4, cisplatin IV continuously on days 1-4, methylprednisolone IV over 15 minutes on days 1-5, and cytarabine IV over 2 hours on day 5. Treatment is repeated every 21 days for up to 4 courses. Arm I: Patients receive filgrastim-SD/01 subcutaneously (SQ) on day 6. Arm II: Patients receive filgrastim (G-CSF) SQ daily beginning on day 6 and continuing for 12 days or until blood counts recover.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within at least 6 months.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of non-Hodgkin's lymphoma (NHL)
o Relapsed disease or Refractory to first line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy
Age 18 and over
ECOG 0-2Absolute neutrophil count at least 1,500/mm3Platelet count at least 150,000/mm3
Creatinine not greater than 1.5 mg/dL or Creatinine clearance greater than 60 mL/min
Fertile patients must use effective barrier contraception
At least 4 weeks since prior radiotherapy
At least 72 hours since prior antimicrobials
At least 30 days since other prior investigational drug
Exclusion Criteria:
No myelodysplastic syndrome or chronic myeloid leukemia
Not pregnant or nursing/Negative pregnancy test
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)
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
No more than 2 prior courses of chemotherapy for any malignancy
No concurrent corticosteroids except topical steroids or as pre-medications or associated with chemotherapy
No other concurrent investigational drug
No concurrent prophylactic antibiotics during course 1
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There are 3 Locations for this study
Los Angeles California, 90095, United States
Omaha Nebraska, 68198, United States
Cleveland Ohio, 44106, United States
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