O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Case Western Reserve University
Arms of the Study
Arm 1
Experimental
Treatment (O6-benzylguanine, 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.