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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003113 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.
Condition | Intervention | Phase |
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Lymphoma |
Biological: filgrastim Drug: cyclophosphamide Drug: etoposide Drug: lomustine Drug: procarbazine hydrochloride Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 32 |
Study Start Date: | July 1997 |
OBJECTIVES:
OUTLINE: All patients receive one cycle of oral chemotherapy, 6 weeks in duration. Etoposide is given on days 1-3 and cyclophosphamide and procarbazine are given on days 22-31 of each cycle. Lomustine is given on day 1 of cycles 1 and 3 only. Filgrastim (granulocyte colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each cycle.
Patients who have disease progression after one cycle of therapy or at any time thereafter are taken off the study. Patients with a complete response after 1 cycle of therapy receive 2 additional cycles of chemotherapy and are observed off treatment. Patients with a partial response (PR) also receive 2 additional cycles of chemotherapy. Following the third cycle of chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive radiation therapy. All other patients with a PR are treated at investigator's discretion.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000065862, CWRU-4496, AMC-1C-93, NCI-G97-1350 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003113 History of Changes |
Health Authority: | United States: Federal Government |
stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage I adult lymphoblastic lymphoma stage I adult Burkitt lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 3 follicular lymphoma |
stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma stage I mantle cell lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II mantle cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II adult lymphoblastic lymphoma |
Immunologic Factors Lymphoma, Mantle-Cell Lomustine Lymphoma, Follicular Mantle Cell Lymphoma Cyclophosphamide Follicular Lymphoma Lymphoblastic Lymphoma Etoposide phosphate Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Alkylating Agents |
Lymphoma Etoposide Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immunosuppressive Agents Lymphatic Diseases Burkitt's Lymphoma Burkitt Lymphoma Antineoplastic Agents, Alkylating Procarbazine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases |
Neoplasms Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Myeloablative Agonists Antineoplastic Agents, Alkylating Procarbazine Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Lymphoma |