Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Objectives

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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

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.

Outline

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

Christopher Schultz, MD, Protocol chair		Ph: 414-805-4472 Email: cschultz@radonc.mcw.edu

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