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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002676 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE II TRIAL OF CHEMOTHERAPY PLUS RADIOTHERAPY FOR MANAGEMENT OF PRIMARY CENTRAL NERVOUS SYSTEM NON-HODGKIN'S LYMPHOMA (PCNSL) |
Estimated Enrollment: | 35 |
Study Start Date: | July 1995 |
OBJECTIVES: I. Assess the response to CHOD (cyclophosphamide/doxorubicin/vincristine/ dexamethasone) and BVAM (carmustine/vincristine/cytarabine/methotrexate) plus whole-brain radiotherapy in patients with primary central nervous system non-Hodgkin's lymphoma (PCNSL). II. Assess the toxic effects associated with this treatment. III.
Assess the survival of patients with PCNSL receiving this treatment. IV. Investigate the frequency of systemic involvement at follow-up. V. Identify factors that appear to be associated with outcome.
OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 BCNU Carmustine, NSC-409962 BVAM BCNU/VCR/ARA-C/MTX CF Leucovorin calcium, NSC-3590 CHOD CTX/DOX/VCR/DM CTX Cyclophosphamide, NSC-26271 DM Dexamethasone, NSC-34521 DOX Doxorubicin, NSC-123127 MTX Methotrexate, NSC-740 VCR Vincristine, NSC-67574 WBRT Whole-Brain Radiotherapy 4-Drug Combination Chemotherapy followed by 4-Drug Combination Chemotherapy followed by Radiotherapy. CHOD; followed by BVAM; followed by WBRT using 4-6 MV equipment (10 MV or greater allowed with proper documentation).
PROJECTED ACCRUAL: Up to 35 patients will be entered over approximately 4.5 years. The study will close early if there is an unacceptable incidence of severe toxicity or treatment failure.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Primary central nervous system non-Hodgkin's lymphoma (PCNSL) Clinically diagnosed intracranial space-occupying lesion Pathology consistent with non-Hodgkin's lymphoma and reviewed by NCCTG Biopsy optional if characteristic history, pathognomonic neuroimaging, and cytology are consistent with malignant lymphocytes from vitrectomy, CSF, or both No occult systemic lymphoma or prior lymphoma No post-transplant lymphoproliferative disorder Disease measurable or evaluable on postoperative contrast-enhanced CT or MRI Postoperative therapy must start within 6 weeks of definitive diagnosis
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-3 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No heart failure No uncontrolled arrhythmia Pulmonary: No severe pulmonary failure Other: No serious uncontrolled infection No active bleeding No AIDS or HIV-positive serology No prior organ transplant No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroids allowed if dose fixed or decreasing for at least 1 week prior to baseline scan Radiotherapy: No prior radiotherapy Surgery: Not specified
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Colorado | |
CCOP - Colorado Cancer Research Program, Inc. | |
Denver, Colorado, United States, 80209-5031 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Louisiana | |
CCOP - Ochsner | |
New Orleans, Louisiana, United States, 70121 | |
United States, Michigan | |
CCOP - Kalamazoo | |
Kalamazoo, Michigan, United States, 49007-3731 | |
United States, Minnesota | |
CCOP - Duluth | |
Duluth, Minnesota, United States, 55805 | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68131 | |
United States, New Jersey | |
CCOP - Northern New Jersey | |
Hackensack, New Jersey, United States, 07601 | |
United States, North Dakota | |
Altru Health Systems | |
Grand Forks, North Dakota, United States, 58201 | |
Quain & Ramstad Clinic, P.C. | |
Bismarck, North Dakota, United States, 58501 | |
United States, Ohio | |
CCOP - Columbus | |
Columbus, Ohio, United States, 43206 | |
CCOP - Toledo Community Hospital Oncology Program | |
Toledo, Ohio, United States, 43623-3456 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57105-1080 | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 |
Study Chair: | Brian P. O'Neill, MD | Mayo Clinic |
Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000064319, NCCTG-937351, E-N9371 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002676 History of Changes |
Health Authority: | United States: Federal Government |
primary central nervous system lymphoma |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Anti-Infective Agents Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Folate Antiemetics Leucovorin Central Nervous System Lymphoma, Primary Cyclophosphamide Hormones Vitamin B9 Lymphoma, Small Cleaved-cell, Diffuse |
Anti-Bacterial Agents Vitamins Cobalt Methotrexate Micronutrients Lymphoma Alkylating Agents Dexamethasone acetate Cytarabine Vitamin B Complex Immunoproliferative Disorders Antineoplastic Agents, Hormonal Carmustine Vincristine Trace Elements |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders |
Immune System Diseases Antineoplastic Agents, Hormonal Carmustine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Immunologic Factors Antineoplastic Agents Leucovorin Cyclophosphamide |