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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carmustine; O(6)-benzylguanine

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