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Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020449 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells. Combining chemotherapy with interleukin-12 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.
Condition | Intervention | Phase |
Sarcoma |
Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Drug: recombinant interleukin-12 |
Phase II |
MedlinePlus related topics: | Cancer Kaposi's Sarcoma Soft Tissue Sarcoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Paclitaxel Interleukin-12 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin-12 |
Study Start Date: | January 2001 |
OBJECTIVES:
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 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Evaluable disease involving the skin and/or viscera
Presence of at least one of the following indications for cytotoxic chemotherapy:
Prior participation on this study allowed, provided patient was removed from study due to non-pancreatic hyperamylasemia and the following are true:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Pallavi P. Kumar, MD | NCI - HIV and AIDS Malignancy Branch |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Little RF, Aleman K, Kumar P, Wyvill KM, Pluda JM, Read-Connole E, Wang V, Pittaluga S, Catanzaro AT, Steinberg SM, Yarchoan R. Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma. Blood. 2007 Dec 15;110(13):4165-71. Epub 2007 Sep 10.
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Little RF, Aleman K, Merced K, et al.: Preliminary results of combination liposomal doxorubicin and interleukin-12 followed by chronic IL-12 maintenance therapy in advanced AIDS-related Kaposi's sarcoma. [Abstract] 10th Conference on Retroviruses and Opportunistic Infections, February 10-14, 2003, Boston, Massachusetts A-816, 2003.
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Study ID Numbers: | CDR0000068502, NCI-01-C-0067, NCI-4010 |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020449 |
Health Authority: | United States: Federal Government |
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