Status:
COMPLETED
A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is administered to patients with advanced Kaposi's sarcoma together with one of two different doses of zidovudine ...
Detailed Description
The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of c...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Medication for grades 1 and 2 oral toxicity. Antiemetic agents, except steroids, for gastrointestinal toxicity. Toxicity grades according to NIAID Recommendations for Grading of Acute and Subacute Toxic Effects (Adults).
Patients must demonstrate any of the following clinical and laboratory findings:
- 25 or more mucocutaneous lesions with or without lymphedema.
- Progressive Kaposi's sarcoma (KS) with 10 or more new lesions in the month prior to study entry or visceral involvement.
- Oral mucosal lesion(s) requiring therapy.
- Prior history of Pneumocystis carinii pneumonia (PCP) or Mycobacterium avium intracellulare.
Patients with any of the following constitutional symptoms with no etiology established may be included:
- Temperature > 38 degrees C and/or drenching night sweats for more than 1 month.
- Watery diarrhea (= or > 3 stools/day) for 2 or more weeks.
- Weight loss > 10 percent of normal. Patients with carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin may be included.
Active alcohol or drug abuse sufficient to prevent adequate compliance with study therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
- Peripheral sensory or motor neuropathy.
- Opportunistic infections requiring therapy.
- Significant pulmonary (exertional dyspnea with minimal exercise) or cardiac insufficiency (New York Heart Association, status > 2).
- Serious neuropsychiatric illness which would prevent informed consent of intensive treatment.
Concurrent Medication:
Excluded:
- Any drugs causing anemia, neutropenia, or significant risk of nephrotoxicity. Patients with a history of other systemic malignancies or lymphomas, except carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin, will be excluded from the study.
Prior Medication:
Excluded:
- Systemic antineoplastic chemotherapy.
- Excluded within 30 days of study entry:
- Any other investigational therapy.
- Antiretroviral agents (zidovudine, ribavirin).
- Immunomodulating agents (steroids, interferons, naltrexone, isoprinosine, and interleukin-2).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1992
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00000987
End Date
April 1 1992
Last Update
November 4 2021
Active Locations (1)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095