Lymphoma Clinical Trial
Official title:
Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome
RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop
growing or die.
PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients
with AIDS-related non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the response rate and duration of response in patients with
AIDS-related non-Hodgkin's lymphoma treated with gallium nitrate after failure on first-line
chemotherapy regimen. II. Determine the qualitative and quantitative toxic effects of this
regimen in these patients. III. Determine the pharmacokinetic parameters of this regimen in
these patients, and determine if there is a correlation between those parameters and
response.
OUTLINE: Patients receive gallium nitrate IV continuously on days 1-7. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve
complete remission (CR) receive 2 additional courses past CR. Patients who relapse after
achieving CR may be retreated in the absence of disease progression. Treatment for relapse
after a second CR is at the discretion of the principal investigator. Patients with
leptomeningeal disease at study entry must receive intrathecal (IT) methotrexate with IV
leucovorin calcium or IT cytarabine. Patients who develop leptomeningeal disease while on
study may continue treatment with gallium nitrate but must also receive IT methotrexate and
leucovorin calcium (with or without radiotherapy) or IT cytarabine. Patients are followed
for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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