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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450320 |
RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sirolimus also may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This pilot study is studying sirolimus in treating patients with HIV-related Kaposi's sarcoma.
Condition | Intervention |
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Sarcoma |
Drug: sirolimus Other: liquid chromatography Other: mass spectrometry |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Pilot Study of Rapamycin in Patients With HIV-Related Kaposi's Sarcoma |
Estimated Enrollment: | 10 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups.
Blood samples are collected periodically and analyzed for sirolimus levels via LCMSMS.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven Kaposi's sarcoma (KS) involving 1 or more of the following tissues:
Gastrointestinal tract and/or lungs, if the disease meets the following criteria:
At least five measurable, previously non-irradiated, cutaneous lesions (indicator lesions)
Serologic documentation of HIV infection (i.e., positive enzyme-linked immunosorbent assay, positive western blot, or other federally approved licensed HIV test, or a detectable blood level of HIV RNA)
PATIENT CHARACTERISTICS:
No acute or known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
PRIOR CONCURRENT THERAPY:
No prior or concurrent treatment with agents or medications, other than antiretroviral drugs used to treat HIV infection, that would interfere with the metabolism or excretion of sirolimus, including, but not limited to, the following:
United States, California | |
Rebecca and John Moores UCSD Cancer Center | Recruiting |
La Jolla, California, United States, 92093-0658 | |
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Susan E. Krown, MD 212-639-7426 krowns@mskcc.org |
Study Chair: | Susan E. Krown, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Dirk Dittmer, PhD | UNC Lineberger Comprehensive Cancer Center |
Responsible Party: | AIDS Associated Malignancies Clinical Trials Consortium ( Jeanette Y. Lee ) |
Study ID Numbers: | CDR0000536481, AMC-051, WYETH-0468X-4420 |
Study First Received: | March 20, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00450320 History of Changes |
Health Authority: | Unspecified |
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Sirolimus Immunologic Factors Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Tioconazole Immunosuppressive Agents Recurrence Herpesviridae Infections |
Kaposi Sarcoma Virus Diseases Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas HIV Infections Antifungal Agents Sarcoma DNA Virus Infections |
Sirolimus Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Sarcoma, Kaposi Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Herpesviridae Infections Virus Diseases Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Neoplasms Antifungal Agents Therapeutic Uses Sarcoma Neoplasms, Vascular Tissue DNA Virus Infections |