A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With… (NCT00000987) | Clinical Trial Compass
CompletedPhase 1
A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
United States36 participants
Plain-language 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 (AZT).
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 combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned.
Who can participate
Age range13 Years
SexALL
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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,…
Trial details
NCT IDNCT00000987
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)