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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000807 |
Purpose
To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy.
Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: Etoposide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy |
| Estimated Enrollment: | 41 |
Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.
Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
Neuropsychiatric history.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| K Norris Cancer Hosp / Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| Denver Dept of Health and Hosps | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Massachusetts | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 100323784 | |
| Adirondack Med Ctr at Saranac Lake | |
| Albany, New York, United States, 122083479 | |
| Mid - Hudson Care Ctr | |
| Albany, New York, United States, 122083479 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Study Chair: | Von Roenn JH | |
| Study Chair: | Paredes J |
More Information
| Study ID Numbers: | ACTG 269 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000807 History of Changes |
| Health Authority: | United States: Federal Government |
|
Sarcoma, Kaposi Etoposide Acquired Immunodeficiency Syndrome |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Infection Etoposide phosphate Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Retroviridae Infections Etoposide RNA Virus Infections Neoplasms by Histologic Type Immune System Diseases |
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic |