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| ID | Type | Description | Link |
|---|---|---|---|
| 11245 | Registry Identifier | DAIDS ES Registry Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Von Roenn JH | Study Chair | |
| Paredes J | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| K Norris Cancer Hosp / Los Angeles County - USC Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Mans D, Sprinz E, Sander I, Kalakun F, Jung G, Prolla G, Schwartsmann G. A phase II study of oral etoposide (VP-16) in AIDS-related Kaposi's sarcoma (KS). Int Conf AIDS. 1994 Aug 7-12;10(1):173 (abstract no PB0118) | ||
| 12149296 | Background | Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. doi: 10.1200/JCO.2002.12.038. |
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| Los Angeles |
| California |
| 900331079 |
| United States |
| Univ of Southern California / LA County USC Med Ctr | Los Angeles | California | 900331079 | United States |
| San Francisco Gen Hosp | San Francisco | California | 941102859 | United States |
| Denver Dept of Health and Hosps | Denver | Colorado | 80262 | United States |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | United States |
| Yale Univ / New Haven | New Haven | Connecticut | 065102483 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | United States |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | United States |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | United States |
| Boston Med Ctr | Boston | Massachusetts | 02118 | United States |
| Adirondack Med Ctr at Saranac Lake | Albany | New York | 122083479 | United States |
| Albany Med College / Division of HIV Medicine A158 | Albany | New York | 122083479 | United States |
| Mid - Hudson Care Ctr | Albany | New York | 122083479 | United States |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | United States |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst | New York | 11373 | United States |
| Saint Clare's Hosp and Health Ctr | New York | New York | 10019 | United States |
| Mount Sinai Med Ctr | New York | New York | 10029 | United States |
| Columbia Presbyterian Med Ctr | New York | New York | 100323784 | United States |
| Julio Arroyo | West Columbia | South Carolina | 29169 | United States |
| ID | Term |
|---|---|
| D012514 | Sarcoma, Kaposi |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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