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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000807
• Other study ID #: ACTG 269
• Secondary ID: 11245
• Status: Completed
• Phase: Phase 2
• Est. completion date: July 2000

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Etoposide

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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)