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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000987
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012

November 2, 1999
March 28, 2012
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Complete list of historical versions of study NCT00000987 on ClinicalTrials.gov Archive Site
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A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
  • Drug: Bleomycin sulfate
  • Drug: Vincristine sulfate
  • Drug: Doxorubicin hydrochloride
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 1992
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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, 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).
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000987
ACTG 075, 11049
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: PS Gill
Study Chair: S Miles
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP