Phase I/II Study of Combination Chemotherapy with CHOD (CTX/ADR/VCR/DM) with or without Intrathecal MTX Followed by Radiotherapy to Treat Primary CNS Lymphomas Localized to the Brain Parenchyma
Basic Trial Information
|Phase II, Phase I||Treatment||Closed||18 and over||NCI||RTOG-8806|
I. Estimate the 2-year survival of patients with primary CNS lymphoma and negative CSF cytology treated with CHOD (cyclophosphamide/adriamycin/vincristine/dexamethasone) in combination with external beam irradiation. II. Estimate the 2-year survival of patients wih primary CNS lymphoma and positive CSF cytology treated with systemic CHOD and intrathecal methotrexate in combination with external beam irradiation. III. Determine the tolerance of these patients to systemic chemotherapy with CHOD and external beam irradiation. IV. Define further the biology of primary CNS lymphoma.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Previously untreated patients at least 18 years of age with histologically confirmed (stereotaxic biopsy is acceptable) primary CNS lymphoma involving the parenchyma of the brain, without evidence of systemic disease. A negative bone marrow biopsy must have been done within 2 weeks prior to entry (multiple samples are required if hemoglobin is 12 g/dl or less). Spinal cord involvement or lymphomatous meningitis without evidence of a parenchymal brain tumor excludes. No prior chemotherapy, radiosensitization, biologic response modifier therapy, or radiotherapy to the head, neck, or spine is allowed. Protocol therapy should begin as soon as possible after diagnosis but no later than 6 weeks after surgery. A Karnofsky performance status of at least 40 and an anticipated life expectancy of at least 8 weeks are required; patients must be HIV-negative. The following organ function parameters are required within 2 weeks of entry: hemoglobin at least 10 g/dl, WBC at least 4,000, platelets at least 150,000, and bilirubin no more than 1.5 mg/dl. There may be no prior malignancy or concurrent second malignancy, other than nonmelanomatous skin cancer, and no medical or psychiatric illness that would prevent treatment as specified in the protocol, completion of treatment, or initiation of full doses of therapy. All patients will be required to have a lumbar puncture for CSF evaluation and a diagnostic postoperative CT scan of the brain prior to initiation of therapy.
In order to obtain 43 negative and 11 positive CSF cytology patients who are evaluable, it is anticipated that 64 patients will need to be entered. At an estimated accrual rate of 30 patients per year, accrual should be completed in 26 months.
Nonrandomized study. Patients with negative CSF cytology receive Regimen A; those with positive CSF cytology receive Regimen B Regimen A: 4-Drug Combination Chemotherapy followed by Radiotherapy. CHOD: Cyclophosphamide, CTX, NSC-26271; Adriamycin, ADR, NSC-123127; Vincristine, Oncovin, VCR, NSC-67574; Decadron, Dexamethasone, DM, NSC-34521; followed by whole-brain irradiation and cone-down boost to primary tumor with megavoltage machines of energies ranging from Co60 through 10 MeV photons. Regimen B: 4-Drug Combination Systemic Chemotherapy plus Single-agent Intrathecal Chemotherapy followed by Radiotherapy. CHOD; plus IT Methotrexate, MTX, NSC-740; followed by Radiotherapy.
Schultz C, Scott C, Sherman W, et al.: Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06. J Clin Oncol 14 (2): 556-64, 1996.[PUBMED Abstract]
Schultz C, Scott C, Sherman W, et al.: Pre-irradiation chemotherapy (CTX) with cytoxan, adriamycin, vincristine, and decadron (CHOD) for primary central nervous system lymphomas: initial report of radiation therapy oncology group protocol 88-06. [Abstract] Proceedings of the International Conference on Brain Tumor Research and Therapy 11: A48, 1995.
Schultz C, Scott C, Wasserman T, et al.: Pre-irradiation chemotherapy (CTX) with cytoxan, adriamycin, vincristine, and decadron (CHOD) for primary central nervous system lymphomas (PCNSL): initial report of Radiation Therapy Oncology Group (RTOG) protocol 88-06. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-485, 174, 1994.
Corn B, Dolinskas C, Scott C, et al.: Strong correlation between imaging response and survival among patients with primary central nervous system lymphoma: a secondary analysis of RTOG studies 83-15 and 88-06. [Abstract] Proceedings of the Society for Neuro-Oncology A25, 1997.
Schultz C, Whittaker M, Kolesar P, et al.: EBV infection in immunocompetent patients with primary CNS lymphoma treated on RTOG 83-15 and 88-06. [Abstract] Proceedings of the Society for Neuro-Oncology A123, 1997.
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
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.