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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000807

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Locations

2.1

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Etoposide	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (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

Actual Study Completion Date :

Jul 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Denver Dept of Health and Hosps	Denver	Colorado	United States	80262
6	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
7	Yale Univ / New Haven	New Haven	Connecticut	United States	065102483
8	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
9	Northwestern Univ Med School	Chicago	Illinois	United States	60611
10	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
11	Boston Med Ctr	Boston	Massachusetts	United States	02118
12	Adirondack Med Ctr at Saranac Lake	Albany	New York	United States	122083479
13	Albany Med College / Division of HIV Medicine A158	Albany	New York	United States	122083479
14	Mid - Hudson Care Ctr	Albany	New York	United States	122083479
15	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
16	City Hosp Ctr at Elmhurst / Mount Sinai Hosp	Elmhurst	New York	United States	11373
17	Saint Clare's Hosp and Health Ctr	New York	New York	United States	10019
18	Mount Sinai Med Ctr	New York	New York	United States	10029
19	Columbia Presbyterian Med Ctr	New York	New York	United States	100323784
20	Julio Arroyo	West Columbia	South Carolina	United States	29169