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Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

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

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Trial Information

Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the
test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV
reverse transcriptase; Phase I and II study benefits of AZT treatment include increased
objective clinical improvement, decreased mortality rate, and decreased incidence of
opportunistic infections. Long-term AZT use, however, presents possible limitations
secondary to intolerance. This study, therefore, will investigate the potential antiviral
activities of a combination of IFN-B and AZT to determine the safety and efficacy of such
treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination
drug therapy consisting of low doses of each drug will reduce the potential of toxicity,
treatment failures, and disease recurrences resulting from drug-resistant virus mutants.

Patients undergo evaluations to determine the extent of their disease and the status of
their immune system. Patients then receive IFN-B subcutaneously once a day at one of three
different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are
treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If
no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients
are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest
tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on
both medications as long as they continue to tolerate the medications and show some
improvement in either antiviral response, immune response, or clinical response for as long
as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site
during which time the patient is trained to self-administer the IFN-B. Patients are then
seen weekly for 4 months and every 2 weeks thereafter.

Inclusion Criteria

Inclusion Criteria

Concurrent Treatment:


- Local radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions,
provided the dose to any one lesion does not exceed 3000 gray and the total surface
area of all lesions treated does not exceed 10 cm2 during the course of the trial.

Patients must demonstrate the following clinical and laboratory findings:

- Positive for HIV by federally licensed ELISA test.

- Acceptable bone marrow function.

- Acceptable renal function.

- Acceptable hepatic function.

Exclusion Criteria

Concurrent Medication:


- Other potentially antiretroviral compounds.

Patients will be excluded from the study for the following reasons:

- Concurrent, active opportunistic infections requiring therapy.

- Extensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic
chemotherapy, prior treatment with more than one chemotherapy regimen, excluding
intralesional therapy, or symptomatic visceral Kaposi's sarcoma.

- Evidence of clinically significant cardiac dysfunction (New York Heart Association
grade III or IV).

- History of malignant neoplasms other than nonmelanomatous skin cancer or cancer in
situ of the cervix.

- Proteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1.

Prior Medication:


- More than one chemotherapy regimen for Kaposi's sarcoma.

- Any interferon preparation or zidovudine (AZT).

- Excluded within 30 days of study entry:

- Other immunomodifiers.

- Acyclovir.

- Other investigational drugs.

- Excluded within 60 days of study entry:

- Cytotoxic therapy.

Patients may not have any of the following diseases or symptoms:

- Development of an AIDS-defining opportunistic infection, other than oral thrush or
localized zoster.

- Non-Kaposi's sarcoma, AIDS-defining malignancy.

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

S Miles

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 057



Start Date:

Completion Date:

July 1991

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Drug Evaluation
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Interferon Type I
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Los Angeles County - USC Med Ctr Los Angeles, California  90033
UCLA CARE Ctr Los Angeles, California  90095
Northwestern Univ Med School Chicago, Illinois  60611
USC School of Medicine / Norris Cancer Hosp Los Angeles, California  90033