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 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.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|Mem Sloan - Kettering Cancer Ctr||New York, New York 10021|