Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma - Article
Clinical Trial: Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|recurrent diffuse small lymphocytic/marginal zone lymphoma |
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
| Drug: cisplatin |
|Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Immune System and Disorders; Lymphatic Diseases; Lymphoma; Vascular Diseases
Study Type: Interventional
Study Design: Educational/Counseling/Training
Study start: May 2000
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.
III. Determine the pharmacokinetic profile of these drugs in course 1 in these patients.
PROTOCOL 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.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within at least 6 months.
Ages Eligible for Study: 18 Years and above
PROTOCOL ENTRY CRITERIA:
- 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
- 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
- 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)
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States
University of Nebraska Medical Center, Omaha, Nebraska, 68198-3330, United States
Ireland Cancer Center, Cleveland, Ohio, 44106-5065, United States
Julie M. Vose, Study Chair, University of Nebraska
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: January 21, 2000
ClinicalTrials.gov Identifier: NCT00004192
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Central Nervous System Lymphoma, Primary (National Cancer Institute)