A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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 AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II trial. AZT has been found to be effective against the effects of HIV in vitro (test tube) and both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and effectiveness of AZT in the combination with IFN-A2A is warranted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AZT has been found to be effective against the effects of HIV in vitro (test tube) and both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and effectiveness of AZT in the combination with IFN-A2A is warranted.

Patients are randomized to receive IFN-A or IFN-A2A by intramuscular injection and combined with AZT orally daily for 8 weeks. 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 escalates only if there is no unacceptable toxicity (grade 2 in = or > 3 patients or > grade 2 in any patients); subsequent increase 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 3 toxicity for hemoglobin or grade 2 toxicity for other parameters in 3 of the 6 patients. Once the MTD is reached, there will be no further enrollment at higher dose level. Patients are followed every week for vital signs and hematologic studies. Patients tolerating the combination may be continued on therapy for 1 year at the same dose as the end of 8th week.

Study Type

Interventional

Enrollment

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patient must have a histologically confirmed diagnosis of Kaposi's sarcoma.
  • Positive antibody to HIV confirmed by ELISA or Western blot on the same serum.

Exclusion Criteria

  • Active drug or alcohol abuse.

Co-existing Condition:

Patients with the following complications are excluded:

  • Active opportunistic infections requiring ongoing therapy.
  • Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90 days prior to study.
  • Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
  • Concurrent neoplasms other than basal cell carcinoma of skin.
  • Known sensitivity to polymycin or neomycin.

Patients with the following complications are excluded:

  • Active opportunistic infections requiring ongoing therapy.
  • Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90 days prior to study.
  • Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
  • Concurrent neoplasms other than basal cell carcinoma of skin.
  • Known sensitivity to polymycin or neomycin.

Prior Medication:

Excluded:

  • Any prior zidovudine (AZT) or interferon alpha protocol participation.
  • Excluded within 30 days of study entry:
  • Immunomodulating agents.
  • Other drugs that can cause neutropenia or significant nephrotoxicity, or systemic anti-infectives.
  • Excluded within 90 days of study entry:
  • Antiretroviral agents.
  • Treatment of Pneumocystis carinii pneumonia (PCP).

Prior Treatment:

Excluded within 30 days of study entry:

  • Radiation therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Krown S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

March 1, 1990

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 014
  • 10990 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe