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A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bleomycin sulfate
Vincristine sulfate
Doxorubicin hydrochloride
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Vincristine, Doxorubicin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Bleomycin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • UCLA CARE Center CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000987
Brief Title
A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
Official Title
A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1992 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 (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.
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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Vincristine, Doxorubicin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Bleomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
Vincristine sulfate
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PS Gill
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
S Miles
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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PubMed Identifier
7534090
Citation
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.
Results Reference
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A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

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