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 Treatment Completed 18 and over NCI NCI-90-C-34 NCI-MB-249, NCI-T89-0194N, T89-0194

Objectives

I.  Determine prospectively the maximum tolerated chemotherapy dose and the 
toxicity, response rate, and survival produced by cytotoxic chemotherapy 
(cyclophosphamide/doxorubicin/etoposide/methotrexate/vincristine with 
leucovorin rescue), azidothymidine, and granulocyte-macrophage colony 
stimulating factor combined with CNS prophylaxis (or treatment) with 
intrathecal methotrexate and cytarabine in patients with AIDS-associated 
non-Hodgkin's lymphoma.
II.  Investigate the molecular and cellular biology, cytogenetics, and cell 
surface markers of AIDS-associated non-Hodgkin's lymphoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 years of age and older 
who are HIV-positive (with or without a previous diagnosis of AIDS or ARC as 
defined by the CDC) and who have biopsy-proven, Stage I/II/III/IV 
intermediate- or high-grade non-Hodgkin's lymphoma (Working Classification), 
including small non-cleaved cell lymphoma, large cell lymphoma, large cell 
immunoblastic lymphoma, and Burkitt's lymphoma.  Diagnosis must be confirmed 
by the NCI Laboratory of Pathology.  Patients with primary CNS lymphoma are 
excluded, as are those with pulmonary Kaposi's sarcoma or known extensive 
gastrointestinal Kaposi's sarcoma.  Patients must be free of clinically active 
opportunistic infection, including CMV retinitis, CNS toxoplasmosis, active M. 
tuberculosis (on treatment), and P. carinii pneumonia treated for less than 2 
weeks; those on DHPG maintenance and those with progressive multifocal 
leukoencephalopathy are ineligible, and those with known MAI involving the 
bone marrow may be excluded.  Previously untreated patients are preferred, but 
patients who have received limited prior radiotherapy may be eligible at the 
discretion of the principal investigator; prior cytotoxic chemotherapy is not 
allowed.  Disease that can be measured or evaluated by physical examination or 
diagnostic test is required, and patients must have a Karnofsky performance 
status of at least 30% and a life expectancy of at least 12 weeks.  Patients 
with a coexistent second malignancy, other than basal or squamous cell 
carcinoma and Kaposi's sarcoma (except as noted above), are ineligible.  
Pregnancy excludes.

Expected Enrollment

It is expected that 14 patients will be accrued per year.

Outline

Nonrandomized study.  All patients receive treatment on Regimen A and receive 
CNS prophylaxis or CNS treatment on Regimen B.
Regimen A:  5-Drug Combination Chemotherapy with Leucovorin Rescue and 
Hematologic Toxicity Attenuation plus Anti-HIV Therapy plus Prophylaxis for P. 
carinii pneumonia.  Cyclophosphamide, CTX, NSC-26271; Etoposide, VP-16, 
NSC-141540; Doxorubicin, DOX, NSC-123127; Vincristine, VCR, NSC-67574; 
Methotrexate, MTX, NSC-740; with Leucovorin calcium, Citrovorum Factor, CF, 
NSC-3590; and Granulocyte-Macrophage Colony Stimulating Factor (Schering), 
GM-CSF, NSC-617589; plus Zidovudine, Azidothymidine, AZT, NSC-602670; plus 
Pentamidine, NSC-620107.
Regimen B:  CNS Prophylaxis/Treatment.  Intrathecal Cytarabine, IT ARA-C, 
NSC-63878; Intrathecal Methotrexate, IT MTX; whole-brain irradiation 
(equipment unspecified).

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Dwight Kaufman, MD, PhD, Protocol chair		Ph: 731-422-0408; 800-372-8221