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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
University of Nebraska
Information provided by: National Cancer Institute (NCI)

Purpose

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
Waldenstrom's Macroglobulinemia
Neutropenia
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
 Drug: cisplatin
 Drug: cytarabine
 Drug: etoposide
 Drug: filgrastim
 Drug: filgrastim-SD/01
 Drug: methylprednisolone
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

Official Title: Phase II Randomized Study of Filgrastim-SD/01 vs Filgrastim (G-CSF) For Neutropenia Following Combination Chemotherapy in Patients with Recurrent Non-Hodgkin's Lymphoma

Further Study Details: 

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.

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.

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.

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

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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)

Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Julie M. Vose,  Study Chair,  University of Nebraska   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067433; UNMC-272-99; NCI-G99-1648; AMGEN-990117; CWRU-AMGN-1499; UCLA-9906080
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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