Trials / Completed
CompletedNCT00058045
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | aldesleukin | |
| BIOLOGICAL | recombinant human stem cell factor |
Timeline
- Start date
- 2002-08-01
- Primary completion
- 2003-11-01
- First posted
- 2003-04-09
- Last updated
- 2013-01-31
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00058045. Inclusion in this directory is not an endorsement.