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 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.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|Univ of Miami School of Medicine||Miami, Florida 331361013|