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Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etoposide
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Sarcoma, Kaposi, Etoposide, Acquired Immunodeficiency Syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
  • Univ of Southern California / LA County USC Med Ctr
  • San Francisco Gen Hosp
  • Denver Dept of Health and Hosps
  • Univ of Colorado Health Sciences Ctr
  • Yale Univ / New Haven
  • Univ of Miami School of Medicine
  • Northwestern Univ Med School
  • Indiana Univ Hosp
  • Boston Med Ctr
  • Adirondack Med Ctr at Saranac Lake
  • Albany Med College / Division of HIV Medicine A158
  • Mid - Hudson Care Ctr
  • SUNY / Erie County Med Ctr at Buffalo
  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
  • Saint Clare's Hosp and Health Ctr
  • Mount Sinai Med Ctr
  • Columbia Presbyterian Med Ctr
  • Julio Arroyo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00000807
Brief Title
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Sarcoma, Kaposi, Etoposide, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
41 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Etoposide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Von Roenn JH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paredes J
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Denver Dept of Health and Hosps
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Yale Univ / New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
065102483
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Boston Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Adirondack Med Ctr at Saranac Lake
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
Albany Med College / Division of HIV Medicine A158
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
Mid - Hudson Care Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Saint Clare's Hosp and Health Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
100323784
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
12149296
Citation
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.
Results Reference
background

Learn more about this trial

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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