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

Lymphoma Clinical Trial

Official title:

A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004192
• Other study ID #: 0272-99-FB
• Secondary ID: P30CA036727AMGEN
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2000
• Est. completion date: March 16, 2001

Study information

• Verified date: December 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 16, 2001
• Est. primary completion date: February 1, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Neutropenia

Intervention

Biological:
• filgrastim

• pegfilgrastim

Drug:
• cisplatin

• cytarabine

• etoposide

• methylprednisolone

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,