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 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 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 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 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
Mem Sloan - Kettering Cancer Ctr
New York, United StatesOpen Mem Sloan - Kettering Cancer Ctr in Google Maps