Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00002578|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : October 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: cytarabine Drug: gallium nitrate Drug: leucovorin calcium Drug: methotrexate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome|
|Study Start Date :||August 1994|
|Actual Primary Completion Date :||January 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002578
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Lawrence P. Leichman, MD||Albany Medical College|