A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
Interferon alfa-2a
+ Zidovudine
+ Interferon alfa-n1
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.56 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Univ of Miami School of Medicine
Miami, United StatesOpen Univ of Miami School of Medicine in Google Maps