Protocol Number: 08-C-0123
-CAT-8015 is composed of a toxin and an antibody that combines with a protein called CD22 that is found on the surface of cancer cells. The drug is designed for the antibody to target the CD22 protein on the cancer cell and for the toxin to kill the cell. -In animal studies, CAT-8015 has killed leukemia cells with the CD22 protein on their surface and decreased tumors in mice. Objectives: -To determine the highest safe dose of CAT-8015 in children and young adults. -To learn how CAT-8015 is broken down in the body. -To determine if CAT-8015 is effective in treating acute lymphocytic leukemia (ALL) and non-Hodgkin's lymphoma (NHL), including lymphoblastic lymphoma, Burkitt's lymphoma or large cell lymphoma. Eligibility: -Patients between 6 months and 25 years of age with ALL or NHL whose disease has not been cured by at least one course of standard chemotherapy and one salvage regimen. -Patients' cancer cells must have the CD22 protein on their surface. Design: -In this dose escalation study, the first group of three to six patients receives the smallest study dose of CAT-8015. Subsequent small groups receive higher doses of the drug as long as the preceding group has not experienced unacceptable side effects. When the highest safe dose is determined, new patients enrolled in the study receive that dose. -Patients receive CAT-8015 in 21-day treatment cycles. The drug is given through a vein in a 30-minute infusion on days 1, 3, 5, 7, 9 and 11 of each cycle. -Patients with ALL also receive chemotherapy directly into the spinal fluid to lessen the risk that the disease will spread to the spine. -Patients may receive up to 6 cycles of the treatment as long as their disease does not worsen and they do not develop severe side effects or make antibodies to the drug. They are followed up to 2 years after stopping treatment. -Before each new cycle, patients have a physical examination, check of vital signs, blood draw, urine sample collection and disease evaluation. The evaluation may include CT or PET scan, bone marrow aspirate and/or biopsy, spinal tap and additional blood tests. -When treatment ends, patients are seen in the clinic for followup at months 1, 3, 6, 12, 15, 18, 21 and 24. They are asked about their health and activity level and have a physical examination, blood tests and disease evaluation as detailed above. -Patients have a final visit 3 months after the study ends or when they leave the study if they withdraw before it ends. This visit includes blood tests, vital signs and weight check, determination of activity level, electrocardiogram and pregnancy test for women who can become pregnant.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/15/2008
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