Clinical Trials Directory

Trials / Terminated

TerminatedNCT00003613

O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma

Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells

Detailed description

PRIMARY OBJECTIVES: I. To determine the kinetics of AGT depletion in CTCL skin lesions. II. To determine the toxicity of low dose BCNU plus O6BG. OUTLINE: This is a dose-escalation study of carmustine. Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed for 6 weeks.

Conditions

Interventions

TypeNameDescription
DRUGO6-benzylguanineGiven IV
DRUGcarmustineGiven topically
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
1999-04-01
Primary completion
2006-05-01
First posted
2003-01-27
Last updated
2013-01-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00003613. Inclusion in this directory is not an endorsement.