Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Sarcoma, Kaposi

HIV Infections

Eligibility:

All Genders

12+ years

Phase:

PHASE2

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 sarco...

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...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

July 1 2000

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00000807

End Date

July 1 2000

Last Update

October 28 2021

Active Locations (20)

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Page 1 of 5 (20 locations)

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

K Norris Cancer Hosp / Los Angeles County - USC Med Ctr

Los Angeles, California, United States, 900331079

3

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States, 900331079

4

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

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