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A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

Phase 1
13 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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

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

Concurrent Medication:


- 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:


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

PS Gill

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 075



Start Date:

Completion Date:

April 1992

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Doxorubicin
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Bleomycin
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma



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