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Sponsored by: |
National Cancer Institute (NCI) |
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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 |
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Sarcoma |
Biological: recombinant interleukin-12 Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
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 |
Study ID Numbers: | CDR0000068502, NCI-01-C-0067, NCI-4010 |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00020449 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Interleukin-12 Immunologic Factors Sarcoma, Kaposi Adjuvants, Immunologic Antimitotic Agents Angiogenesis Inhibitors Recurrence Doxorubicin Herpesviridae Infections Kaposi Sarcoma |
Virus Diseases Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas Paclitaxel Tubulin Modulators Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic |
Interleukin-12 Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents Neoplasms by Histologic Type Growth Substances Sarcoma, Kaposi |
Mitosis Modulators Adjuvants, Immunologic Antimitotic Agents Angiogenesis Inhibitors Doxorubicin Pharmacologic Actions Herpesviridae Infections Virus Diseases Neoplasms Paclitaxel Tubulin Modulators Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic |