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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: | NCT00064142 |
RATIONALE: Topical halofuginone hydrobromide ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well topical halofuginone hydrobromide works in treating patients with HIV-related Kaposi's sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: halofuginone hydrobromide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Trial of Topical Halofuginone in Patients With HIV Related Kaposi's Sarcoma |
Estimated Enrollment: | 30 |
Study Start Date: | May 2003 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study, with subsequent open-label treatment in stable or responding patients. Twelve treatable Kaposi's sarcoma lesions are selected on each patient, and these 12 lesions are randomized equally to 1 of 2 treatment arms (6 lesions receive study treatment and 6 lesions receive placebo); each patient serves as his/her own control.
Patients with stable or responding disease in either or both groups of treated lesions (halofuginone hydrobromide ointment or placebo ointment) may receive open-label treatment with topical halofuginone hydrobromide ointment to all 12 lesions for an additional 12 weeks as above in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven Kaposi's sarcoma (KS)
At least 14 cutaneous lesions, 12 of which are bidimensionally measurable and can serve as marker lesions
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Renal
Other
No acute, active, untreated opportunistic infection within the past 14 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids
Radiotherapy
Surgery
Other
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
United States, Hawaii | |
Leahi Hospital | |
Honolulu, Hawaii, United States, 96816 | |
United States, Louisiana | |
Tulane Cancer Center at Tulane University Hospital and Clinic | |
New Orleans, Louisiana, United States, 70112-2699 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Washington | |
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center | |
Seattle, Washington, United States, 98111 |
Study Chair: | Susan E. Krown, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Henry Koon, MD | Beth Israel Deaconess Medical Center |
Investigator: | Merrill J. Egorin, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000309055, AMC-036, CWRU-040332 |
Study First Received: | July 8, 2003 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00064142 |
Health Authority: | United States: Federal Government |
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Recurrence Soft tissue sarcomas Herpesviridae Infections Virus Diseases |
Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sarcoma DNA Virus Infections Halofuginone |
Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Antiparasitic Agents Therapeutic Uses Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents Coccidiostats |