Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Supportive care, Treatment Closed 18 to 70 NIAID NIAID-ATEU-009 NCI-V87-0223

Objectives

I.  Evaluate the safety and toxicity of dexamethasone/methotrexate/citrovorum 
factor administered concurrently with azidothymidine and radiotherapy to the 
brain in patients with AIDS-related primary CNS lymphoma.
II.  Evaluate preliminarily the effects of this regimen on response rate and 
survival.
III.  Assess the incidence of opportunistic infection in these patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 to 70 years of age with 
newly diagnosed, previously untreated, pathologically confirmed CNS lymphoma 
who have HIV antibody, positive HIV culture or antigen capture assay, or a 
prior diagnosis of AIDS.  Measurable disease parameters are required.  
Patients must have a Karnofsky performance status of at least 50% and adequate 
hepatic (bilirubin less than 2.0 mg/dl, SGOT less than 3 times normal), renal 
(creatinine less than 1.5 times the upper limit of normal or creatinine 
clearance at least 60 ml/min), and bone marrow (granulocytes greater than 
1,500/dl, platelets greater than 100,000/dl, Hb at least 9.5 g/dl) function.  
Patients who have received antiretroviral agents other than AZT during the 14 
days prior to entry are ineligible; patients who have been on AZT may have 
this drug continued as per protocol.  Patients who require treatment with 
corticosteroids or non-steroidal anti-inflammatory drugs are ineligible.  The 
presence of an acute intercurrent infection, lymphoma in sites outside the 
CNS, a second active tumor other than nonmelanomatous skin cancer or Kaposi's 
sarcoma, or lymphomatous meningitis alone without a mass lesion in the brain 
excludes.  Pregnant women and nursing mothers are excluded; women of 
child-bearing potential must have a negative pregnancy test within 14 days of 
entry and must be willing to abstain from sex or employ appropriate birth 
control.  In participating institutions where pathologic confirmation of CNS 
lymphoma cannot be obtained, patients may be considered eligible if 
space-occupying lesions have been demonstrated on CT or MRI scan; there must 
be negative titers for toxoplasmosis or a negative response to empiric therapy 
for intracerebral toxoplasmosis and negative work-up for other infectious 
etiology of CNS disease.  This subgroup of patients will be treated on 
protocol, but will be analyzed separately from those with biopsy-proven 
disease.

Expected Enrollment

Twenty patients will be entered and treated; if at least 15 or 3 or fewer 
responses are observed, the study will be terminated.  If more than 3 but 
fewer than 15 responses are observed, 25 additional patients will be entered.

Outline

Nonrandomized study.
Radiotherapy plus 2-Drug Combination Chemotherapy with Leucovorin Rescue plus 
Single-agent Antiviral Therapy.  Cranial irradiation using linear accelerator, 
external beam, photon energy from 4-23 MV; plus Dexamethasone, DM, NSC-34521; 
Methotrexate, MTX, NSC-740; with Citrovorum Factor, CF, NSC-3590; plus 
Azidothymidine, AZT, NSC-602670.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Alexandra Levine, MD, Protocol chair		Ph: 323-865-3913; 800-865-0102