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

Stopped early · Phase 1

Conditions studied: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma

In brief

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

Key facts

Study ID

NCT00003613

Run by

National Cancer Institute (NCI)

People needed

20

Starts

1999-04-01

Last updated by the study team

2013-01-11

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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