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Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: January 21, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004192
  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
Cancer-Related Problem/Condition
Lymphoma
Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: cytarabine
Drug: etoposide
Drug: methylprednisolone
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Cytarabine hydrochloride Cisplatin Etoposide Methylprednisolone Filgrastim Pegfilgrastim Cytarabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: May 2000
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
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

Study ID Numbers: CDR0000067433, UNMC-272-99, AMGEN-990117, CWRU-AMGN-1499, UCLA-9906080, NCI-G99-1648
Study First Received: January 21, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004192     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Antimetabolites
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Lymphoma, Mantle-Cell
Hormones, Hormone Substitutes, and Hormone Antagonists
Lymphoma, Follicular
Antiemetics
Prednisolone acetate
Lymphoma, B-Cell, Marginal Zone
Mantle Cell Lymphoma
Hormones
Neuroprotective Agents
Etoposide phosphate
Follicular Lymphoma
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Cisplatin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Leukemia, B-cell, Chronic
Lymphoma, Large-cell
Etoposide
Lymphoma
Cytarabine
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Therapeutic Uses
Lymphoma
Cytarabine
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Glucocorticoids
Protective Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009