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O6-Benzylguanine and Topical Carmustine in Treating Patients With Stage IA or Stage IIA Cutaneous T-Cell Lymphoma That Has Not Responded to Treatment

2014-08-27 03:19:56 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help carmustine work better by making cancer cells more sensitive to the drug.

PURPOSE: This phase I/II trial is studying the side effects of giving O6-benzylguanine together with topical carmustine and to see how well it works in treating patients with stage IA or stage IIA cutaneous T-cell lymphoma that has not responded to treatment.

Description

OBJECTIVES:

- To determine the response rate and safety of O6-benzylguanine (O6BG) and topical carmustine when given biweekly as 2 consecutive daily doses in patients with refractory stage IA-IIA cutaneous T-cell lymphoma (CTCL).

- To determine the laboratory correlates of clinical response and drug efficacy based upon O6-alkylguanine DNA alkyltransferase (AGT) activity in CTCL lesions and the effects of consecutive-day O6BG administration on the extent and duration of AGT depletion.

- To determine the laboratory correlates of clinical response and drug efficacy based upon degree of induction of apoptosis and cell cycle arrest in the malignant T-cell population of lymphomatous tissue and in the constitutive cells of the skin to determine drug efficacy and toxicity through immunohistochemical techniques.

- To determine the laboratory correlates of clinical response and drug efficacy based upon MGMT gene mutations and changes in AGT expression as potential mechanisms for O6BG resistance in non-responding patients.

OUTLINE: This is a multicenter, phase I, dose-escalation study of carmustine followed by a phase II study.

Patients receive O6-benzylguanine (O6BG) IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6BG infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Tissue and blood samples may be collected for further analysis.

After completion of study treatment, patients are followed at 2 weeks.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

O6-benzylguanine, carmustine, laboratory biomarker analysis, biopsy

Location

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Cleveland
Ohio
United States
44106

Status

Recruiting

Source

Case Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:56-0400

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