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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00004192
First received: January 21, 2000
Last updated: June 23, 2010
Last verified: June 2010
  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 Intervention Phase
Lymphoma
Neutropenia
Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: cytarabine
Drug: etoposide
Drug: methylprednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Estimated Enrollment: 60
Study Start Date: May 2000
Study Completion Date: March 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Detailed 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004192

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004192     History of Changes
Other Study ID Numbers: 272-99, P30CA036727, UNMC-272-99, AMGEN-990117, CWRU-AMGN-1499, UCLA-9906080, NCI-G99-1648
Study First Received: January 21, 2000
Last Updated: June 23, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Nebraska:
neutropenia
Waldenstrom macroglobulinemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Cisplatin
Cytarabine
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Lenograstim
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 23, 2014