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

• Status: Completed
• Trial end date: 1990-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated dose of each drug in combination and to define doses to be used in Phase II trials. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Zidovudine

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.