Phase I clinical trial of O6-benzylguanine and topical carmustine in the treatment of cutaneous T-cell lymphoma, mycosis fungoides type.

ABSTRACT:

Objectives

To evaluate the toxic effects and maximum tolerated dose of topical carmustine [1,3-bis(2-chloroethyl)-1-nitrosourea] following intravenous O6-benzylguanine in the treatment of cutaneous T-cell lymphoma (CTCL), and to determine pharmacodynamics of O6-alkylguanine DNA alkyltransferase activity in treated CTCL lesions.

Design

Open-label, dose-escalation, phase I trial.

Setting

Dermatology outpatient clinic and clinical research unit at a university teaching hospital.

Patients

A total of 21 adult patients (11 male, 10 female)with early-stage (IA-IIA) refractory CTCL, mycosis fungoides type, treated with topical carmustine following intravenous O6-benzylguanine.

Intervention

Treatment once every 2 weeks with 120 mg/m(2) intravenous O6-benzylguanin

SUBMITTER: Apisarnthanarax N 

PROVIDER: S-EPMC3519426 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature