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Keep this study
Lead
National Cancer Institute (NCI)
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.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed CTCL, stages IA-IIA
Performance status ECOG grade 0, 1, or 2
Patients must have recovered from toxicity of prior treatment and have received no CTCL therapy other than emoliation for at least 4 weeks
Patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects
WBC \> 4,000/ul
ANC \> 2,000/ul
Platelets \> 100,000/ul
Bilirubin \< 1.5 mg/dL
SGOT within normal range
Prothrombin time within normal range
Creatinine =\< 1.5 mg/dL or creatinine clearance \>= 70 ml/min
Calcium and electrolytes normal
Glucose-controlled (diet and insulin) diabetes is permitted
DLCO \> 80% normal with the exception of patients who demonstrate clinically normal lung function based on history, physical examination, and chest x-ray as interpreted by the principal investigator
Only those patients with biopsiable tumor and willing to undergo several biopsies will be eligible
Must have failed 1 conventional treatment other than topical corticosteroids; this includes UVB, PUVA, topical mechlorethamine, electron beam, photopheresis, chemotherapy and immuno-modulatory agents such as cytokines
You may not be if
Patients with a prior treatment with a nitrosourea
Patients with known central nervous system involvement or primary CNS malignancies will be ineligible
Patients with performance status ECOG grade 3 or 4
Pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception, because of potential toxicity to the fetus or infant
Patients with active infection
Patients with pulmonary disease as determined by history, physical examination, chest X-ray or pulse oximetry
CTCL patients with stage IIB-IVB disease
Clareo Health | O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma
