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A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma


AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of
HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in
Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced
antitumor response may be seen with combination therapy. A study to evaluate the safety and
efficacy of AZT in combination with IFN-A or IFN-A2A is warranted.

Patients are randomized to receive IFN-A or IFN-A2A (given by intramuscular injection) and
combined with AZT (taken orally) daily for 8 weeks. Study stops when maximum tolerated dose
(MTD) is reached. Two cohorts of 4 patients enter each dose level. Patients do not enter
into the next dose level until all patients have completed 3 weeks of treatment. AZT will
escalate only if there is no unacceptable toxicity (grade 2 in = or > 3 patients or > grade
2 in any patient), subsequent increases in IFN-A or IFN-A2A will be permitted, but the AZT
dose will remain fixed. The MTD for a given IFN-A or IFN-A2A dose level is defined as grade
2 toxicity (grade 3 for hemoglobin, neutrophil count, or SGOT) in 4 of the 6 patients.
Patients have blood drawn every week and their general health is evaluated. Pharmacokinetic
studies will be done on days 1, 21, and 24. Patients tolerating the combination may be
continued on the same dose level for 1 year except if patient has reached complete remission
for = or > 90 days, IFN-A or IFN-A2A will decrease to 3 times a week.

Inclusion Criteria


Inclusion Criteria

- Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma.

- Evidence of HIV infection as manifested by a positive antibody test.

Exclusion Criteria

- Active drug or alcohol abuse.

Co-existing Condition:

Excluded are patients with:

- Active opportunistic infections requiring ongoing therapy.

- Excluded within 90 days of study entry:

- Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.

- Clinically significant cardiac disease, including a history of myocardial infarction
or arrhythmia.

- Concurrent neoplasms other than basal cell carcinoma of the skin.

- Known hypersensitivity to polymycin B or neomycin.

Excluded are patients with:

- Active opportunistic infections requiring ongoing therapy.

- Excluded within 90 days of study entry:

- Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.

- Clinically significant cardiac disease, including a history of myocardial infarction
or arrhythmia.

- Concurrent neoplasms other than basal cell carcinoma of the skin.

- Known hypersensitivity to polymycin B or neomycin.

Prior Medication:

Excluded:

- Interferon.

- Zidovudine (AZT).

- Excluded within 30 days of study entry:

- Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents.

- Other drugs which can cause neutropenia or significant nephrotoxicity.

- Rifampin or rifampin derivatives, or systemic anti-infectives.

- Excluded within 90 days of study entry:

- Other antiviral agents.

- A history of Pneumocystis carinii pneumonia (PCP) completed treatment.

Prior Treatment:

Excluded within 30 days of study entry:

- Radiation therapy.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Fischl MA

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 013

NCT ID:

NCT00000725

Start Date:

Completion Date:

February 1990

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Interferon Alfa-2a
  • Sarcoma, Kaposi
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Interferon Type I
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Univ of Miami School of MedicineMiami, Florida  331361013