Interleukin-12 in Treating Patients With AIDS-Related Kaposi's Sarcoma
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|ClinicalTrials.gov Identifier: NCT00019188|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : June 20, 2013
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill their tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of interleukin-12 in treating patients with AIDS -related Kaposi's sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Epidemic Kaposi's Sarcoma Recurrent Kaposi's Sarcoma||Drug: interleukin-12||Phase 1 Phase 2|
OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-12 (IL-12) in patients with AIDS-associated Kaposi's sarcoma.
II. Determine the antitumor activity of IL-12 in these patients. III. Determine the effect of IL-12 on angiogenic factors, including basic fibroblast growth factor, vascular endothelial growth factor, and interferon-inducible protein 10 in these patients.
IV. Determine the immunologic and virologic effects of IL-12 in these patients.
PROTOCOL OUTLINE: This is a dose escalation study. Patients receive interleukin-12 (IL-12) subcutaneously twice a week (at least 3 days apart) for 6 months. Patients with stable or better disease continue IL-12 treatment in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Ten additional patients are treated at the MTD.
Patients are followed at 4 weeks.
Up to 55 patients will be entered over approximately 4.0 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/II Pilot Study of Interleukin-12 in Patients With AIDS-Associated Kaposi's Sarcoma|
|Study Start Date :||January 1997|
|Actual Study Completion Date :||March 2007|
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): NCT00019188
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Robert Yarchoan||National Cancer Institute (NCI)|