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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000807
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 41
Study Completion Date: July 2000
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000807

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
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
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
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
Mid - Hudson Care Ctr
Albany, New York, United States, 122083479
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
Adirondack Med Ctr at Saranac Lake
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
Mount Sinai Med Ctr
New York, New York, United States, 10029
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
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Von Roenn JH
Study Chair: Paredes J
  More Information

Additional Information:
Publications:
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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000807     History of Changes
Other Study ID Numbers: ACTG 269, 11245
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sarcoma, Kaposi
Etoposide
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014