Combination Therapy for Patients with Condyloma Acumina

Reichman, Richard

Abstract

The objective of this project is the development of a safe and effective combination treatment regimen for condyloma acuminatum. Three groups of Phase I/II studies will be conduced. The first group will examine the efficacy and toxicity of cryotherapy with liquid nitrogen in combination with parenterally administered alpha, beta, or gamma interferon (or placebo). The second group of Phase I/II studies will examine the efficacy and toxicity of topically applied podophyllotoxin (or placebo). In the third group of Phase I/II studies, interferon combinations will be evaluated. Specifically, either intralesionally (or subcutaneously) administered alpha and beta interferons (or placebo) will be used in combination with parenterally administered gamma interferon (or placebo). The primary purpose of these Phase I/II studies will be to select the best candidate combination therapy regimens to be employed in definitive, Phase III study. Efficacy will be determined primarily on the basis of sequential measurements of typical exophytic lesions of condyloma acuminatum. In addition, virologic studies will be conducted, as well as studies of drug measurements in serum and development of antibodies to interferons. Placebo arms will be included in the study design, and in addition to effects of combination therapy, the effects of each agent given alone will be examined.