A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin-12
- Determine the overall response rate in patients with AIDS-associated Kaposi's sarcoma
(KS) treated with doxorubicin HCl liposome and interleukin-12.
- Determine the time to response and the number of complete responses in patients treated
with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Provide pilot information on the ability of interleukin-12 to maintain major responses
induced with paclitaxel salvage therapy in patients with aggressive or life-threatening
KS after treatment failure with doxorubicin HCl liposome and interleukin-12.
- Determine the effect of this regimen on CD4 counts and viral load in these patients.
OUTLINE: Patients receive doxorubicin HCl liposome (LipoDox) IV over 30 minutes once every 3
weeks for a total of 6 doses. Beginning concurrently with the initiation of LipoDox,
patients also receive interleukin-12 (IL-12) subcutaneously twice weekly (at least 3 days
apart) for up to 3 years.
Patients with refractory disease are transferred to the paclitaxel salvage therapy regimen
comprising paclitaxel IV continuously on days 1-4 once every 3 weeks until a major response
is achieved. Beginning concurrently with the initiation of paclitaxel salvage therapy,
patients also receive IL-12 as above for up to 3 years.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete response may discontinue IL-12 administration. If necessary, IL-12
treatment may resume at a later time.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2-4
Masking: Open Label, Primary Purpose: Treatment
Pallavi P. Kumar, MD
NCI - HIV and AIDS Malignancy Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|