Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase I/II Multicenter Clinical Trial of O6Benzylguanine and Topical Carmustine in the Treatment of Refractory Early-Stage (IA-IIA) Cutaneous T-Cell Lymphoma
This phase I/II trial studies the side effects and best dose of carmustine when given together with O6-benzylguanine and to see how well they work in treating patients with stage IA-IIA cutaneous T-cell lymphoma. 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. Giving O6-benzylguanine with carmustine may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the cutaneous T-cell Lymphoma (CTCL) response rate and safety of O6BG
(O6-benzylguanine) /BCNU (carmustine) when given biweekly as two consecutive daily doses.
SECONDARY OBJECTIVES:
I. To determine the laboratory correlates of clinical response and drug efficacy based upon
O6-alkylguanine deoxyribonucleic acid (DNA) alkyltransferase (AGT) activity in CTCL lesions
will be examined to determine the effects of consecutive day O6BG administration on the
extent and duration of AGT depletion.
II. To determine the laboratory correlates of clinical response and drug efficacy based upon
degree of induction of apoptosis and cell cycle arrest will be examined 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.
III. To determine the laboratory correlates of clinical response and drug efficacy based upon
O-6-methylguanine-DNA methyltransferase (MGMT) gene mutations and changes in AGT expression
will be examined as potential mechanisms for O6BG resistance in non-responding patients.
OUTLINE: This is a phase I, dose-escalation study of carmustine followed by a phase II study.
Patients receive O6-benzylguanine intravenously (IV) over 1 hour and apply topical carmustine
to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after
completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to
12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks.
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