A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
NCT ID: NCT00000987
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
1992-04-30
Brief Summary
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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.
Detailed Description
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AMENDED: AZT by mouth. If the treatment is well tolerated, subsequent groups of patients are started on increasing doses of doxorubicin combined with the same dose of bleomycin and vincristine. After determination of the MTD of chemotherapy in combination with AZT, the 2nd phase begins in which AZT is given and the first group of patients is given bleomycin and vincristine only. If this combination is well tolerated, then the subsequent groups are started on increasing doses of doxorubicin with the same dose of bleomycin, vincristine and AZT. The MTD of chemotherapy in combination with AZT is then determined. Patients achieving maximum response to the tumor are maintained on AZT alone. This is an outpatient study, and patients are seen every 2 weeks for evaluation, with a physical examination every month. Original design: The combination of chemotherapy and AZT is given to groups of four patients each, the first group beginning with bleomycin and vincristine, without the addition of doxorubicin. The chemotherapy is given intravenously every 2 weeks. This is combined first with AZT by mouth.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Bleomycin sulfate
Vincristine sulfate
Doxorubicin hydrochloride
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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).
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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PS Gill
Role: STUDY_CHAIR
S Miles
Role: STUDY_CHAIR
Locations
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UCLA CARE Center CRS
Los Angeles, California, United States
Countries
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References
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Brambilla D, Coombs R, Bremer JW, Reichelderfer PS, Kalish L, Shapiro DE. The contributions of assay variation and biological variation to the variability of HIV RNA measurements in serially collected clinical specimens. Int Conf AIDS. 1998;12:805 (abstract no 42163)
Gill PS, Miles SA, Mitsuyasu RT, Montgomery T, McCarthy S, Espina BM, Feldstein M, Levine AM. Phase I AIDS Clinical Trials Group (075) study of adriamycin, bleomycin and vincristine chemotherapy with zidovudine in the treatment of AIDS-related Kaposi's sarcoma. AIDS. 1994 Dec;8(12):1695-9. doi: 10.1097/00002030-199412000-00009.
Other Identifiers
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11049
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 075
Identifier Type: -
Identifier Source: org_study_id