Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00004192 |
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Recruitment Status :
Completed
First Posted : June 25, 2004
Last Update Posted : January 17, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma Neutropenia | Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: cytarabine Drug: etoposide Drug: methylprednisolone | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| 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 |
| Study Start Date : | May 2000 |
| Actual Primary Completion Date : | February 2001 |
| Actual Study Completion Date : | March 2001 |
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004192
| 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 | |
| Study Chair: | Julie M. Vose, MD | University of Nebraska |
| Responsible Party: | Julie M Vose, MD, Principal Investigator, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00004192 |
| Other Study ID Numbers: |
272-99 P30CA036727 ( U.S. NIH Grant/Contract ) UNMC-272-99 AMGEN-990117 CWRU-AMGN-1499 UCLA-9906080 NCI-G99-1648 |
| First Posted: | June 25, 2004 Key Record Dates |
| Last Update Posted: | January 17, 2018 |
| Last Verified: | January 2018 |
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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 |
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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 Cytarabine Methylprednisolone |
Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Etoposide Prednisolone hemisuccinate Prednisolone phosphate Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |