Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
2 other identifiers
interventional
41
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
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
Related Publications (2)
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)
BACKGROUNDEvans 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.
PMID: 12149296BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Von Roenn JH
- STUDY CHAIR
Paredes J
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
July 1, 2000
Last Updated
October 28, 2021
Record last verified: 2021-10