Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
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|ClinicalTrials.gov Identifier: NCT00058045|
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : January 31, 2013
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy.
PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: aldesleukin Biological: recombinant human stem cell factor||Phase 1|
- Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies.
- Determine the immune status of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of stem cell factor.
Patients receive interleukin-2 (IL-2) subcutaneously (SC) six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 3 patients receives treatment at the MTD.
Patients are followed every 2 weeks for 1 month.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Official Title:||A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 (IL-2) And Stem Cell Factor (r-metHuSCF) For Patients With AIDS And AIDS-Associated Malignancy|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||November 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058045
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210|
|Study Chair:||Zale P. Bernstein, MD||Roswell Park Cancer Institute|