Protocol Number: 03-C-0194
Patients 18 years of age and older with any type of ATL except smoldering may be eligible for this study. Candidates will be screened with a medical history and physical examination, photos of skin lesions, measurement of lesions such as lymph nodes and skin nodules, blood and urine tests, electrocardiogram (EKG), chest x-ray, CT scan or ultrasound of the abdomen, skin biopsy, bone marrow aspirate and biopsy, skin test, and lumbar puncture (spinal tap). Participants will undergo treatment in two phases, as follows: - Dose escalation phase: Patients will receive an infusion of Campath-1H daily. The initial dose will be low and will be increased daily as long as there are no side effects, or only mild reactions, until the patient is receiving the maximum dose of 30 milligrams per day. - Stable dose phase: Patients will receive three infusions of Campath-1H per week for up to 12 weeks. In addition, patients will be evaluated during treatment with the following tests and procedures: - History and physical examination every 4 weeks. - Blood tests every 4 weeks. - CT scans to measure the size of the tumors every 4 weeks. - Skin biopsies and lymph note aspirates: Up to five biopsies and five aspirates may be taken to help diagnose the disease and evaluate the effect of Campath-1H on the cancer. - Bone marrow or lymph node biopsy: These procedures may be done to document or monitor disease progress. Patients will receive treatment for up to 12 weeks as long as the patient is benefiting. If all the cancer disappears early in the early course of treatment, Campath-1H will be stopped after 8 weeks. Patients whose cancer worsens with treatment will be taken off the medication.
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