Phase II Intergroup Study of Combined Modality Therapy Using MTX/VCR/PCB/DM Followed by Radiotherapy plus ARA-C for Primary CNS Lymphoma
Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Primary CNS Lymphoma
Basic Trial Information
|Phase II||Treatment||Closed||over 18||NCI||RTOG-9310|
I. Assess the rate of tumor response to methotrexate/vincristine/procarbazine/dexamethasone administered prior to radiotherapy in patients with primary central nervous system lymphoma. II. Compare survival of these patients to historical controls treated with radiotherapy alone. III. Assess the long-term toxicity of this regimen. IV. Provide data for consideration of a randomized trial to compare chemotherapy alone vs. chemotherapy plus radiotherapy in an effort to reduce the morbidity of cranial irradiation.
Histologically proven non-Hodgkin's lymphoma of the brain Registration within 4 weeks of histologic diagnosis required Patients with inconclusive biopsy or who are not candidates for brain biopsy eligible provided: Cranial CT or MRI indicates no leptomeningeal nonparenchymal lymphoma Non-Hodgkin's lymphoma is documented by CSF cytology or by vitreous or uveal biopsy Concurrent registration on protocol RTOG 9308 (tissue repository study) allowed
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior cranial irradiation Surgery: Not specified
Age: Over 18 Performance status: Karnofsky 50%-100% Life expectancy: At least 8 weeks Hematopoietic: ANC at least 2,000 Platelets at least 100,000 Hepatic: Bilirubin no more than 2.0 mg/dL AST no more than 2 times normal Renal: Creatinine clearance at least 50 mL/min/1.73 sqm Serum electrolytes normal Other: HIV negative No pre-existing immunodeficiency (e.g., prior renal transplant) No second malignancy within 5 years except: Basal cell carcinoma of the skin In situ cervical carcinoma No pregnant or nursing women
A total of 28 patients will be entered over approximately 10 months. As of 08/96, 40 additional patients will be entered over approximately 20 months.
Patients are sequentially treated on Regimens A, B, and C. The following acronyms are used: ARA-C Cytarabine, NSC-63878 CF Leucovorin calcium, NSC-3590 DM Dexamethasone, NSC-345211 MTX Methotrexate, NSC-740 PCB Procarbazine, NSC-77213 VCR Vincristine, NSC-67574 WBI Whole-Brain Irradiation Regimen A: 4-Drug Combination Chemotherapy plus CNS Therapy. DM; MTX/CF; VCR; PCB; plus IT MTX. Regimen B: Cranial Irradiation. WBI using Co60 or megavoltage equipment up to 10 MV photons. Regimen C: Single-Agent Chemotherapy. ARA-C.
Fisher B, Seiferheld W, Schultz C, et al.: Secondary analysis of Radiation Therapy Oncology Group study (RTOG) 9310: an intergroup phase II combined modality treatment of primary central nervous system lymphoma. J Neurooncol 74 (2): 201-5, 2005.[PUBMED Abstract]
DeAngelis LM, Seiferheld W, Schold SC, et al.: Combination chemotherapy and radiotherapy for primary central nervous system lymphoma: Radiation Therapy Oncology Group Study 93-10. J Clin Oncol 20 (24): 4643-8, 2002.[PUBMED Abstract]
Fisher BJ, Seiferheld W, Schultz C, et al.: Secondary analysis of RTOG 9310: an intergroup phase II combined modality treatment of primary central nervous system lymphoma with chemotherapy and hyperfractionated radiotherapy. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-302, 166, 2001.
DeAngelis L, Seiferheld W, Schold S, et al.: Combined modality treatment of primary central nervous system lymphoma (PCNSL): RTOG 93-10.. [Abstract] Proceedings of the American Society of Clinical Oncology 18: 537A, 140a, 1999.
Schultz C, Scott C, DeAngelis L, et al.: Radiation therapy (RT) alone vs. pre-RT chemotherapy (CTX) for the treatment of primary CNS lymphoma (PCNSL): age matched survival analysis of RTOG 83-15 and RTOG 93-10. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A617, 2000.
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
Ph: 212-639-7997; 800-525-2225
Southwest Oncology Group
Ph: 216-444-6823; 800-862-7798
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.