Lymphoma Clinical Trial
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
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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