Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
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ClinicalTrials.gov Identifier: NCT00000807 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: March 29, 2012
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Etoposide | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 41 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Completion Date : | July 2000 |

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Maintenance therapy for opportunistic infections.
Patients must have:
- HIV infection.
- Kaposi's sarcoma that has relapsed or progressed.
- Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions).
- NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted).
- Consent of parent or guardian if less than 18 years of age.
NOTE:
- This study is approved for prisoner participation.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Grade 3 or worse peripheral neuropathy.
- Altered mental status that would prevent informed consent or prevent study compliance.
Patients with the following prior condition are excluded:
Neuropsychiatric history.
Prior Medication:
Excluded:
- Prior etoposide.
- Any other anti-KS drugs within 14 days prior to study entry.
- Any investigational drug other than antiretrovirals within 14 days prior to study entry.
- Any prior investigational agent, if given as the ONLY prior treatment for KS.
Prior Treatment:
Excluded:
- Radiation therapy within 7 days prior to study entry.
Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000807
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, Colorado | |
Denver Dept of Health and Hosps | |
Denver, Colorado, United States, 80262 | |
Univ of Colorado Health Sciences Ctr | |
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 | |
Adirondack Med Ctr at Saranac Lake | |
Albany, New York, United States, 122083479 | |
Albany Med College / Division of HIV Medicine A158 | |
Albany, New York, United States, 122083479 | |
Mid - Hudson Care Ctr | |
Albany, New York, United States, 122083479 | |
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 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Columbia Presbyterian Med Ctr | |
New York, New York, United States, 100323784 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Von Roenn JH | ||
Study Chair: | Paredes J |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000807 History of Changes |
Other Study ID Numbers: |
ACTG 269 11245 ( Registry Identifier: DAIDS ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | March 29, 2012 |
Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sarcoma, Kaposi Etoposide Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Etoposide Etoposide phosphate Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |