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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00089349 |
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving alemtuzumab with or without methotrexate and mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: alemtuzumab Drug: mercaptopurine Drug: methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Campath-1H In Children With Acute Lymphoblastic Leukemia In Second or Greater Relapse or Twice Induction Failure |
Estimated Enrollment: | 25 |
Study Start Date: | July 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
NOTE: * CNS-negative patients receive methotrexate intrathecally on day 15 of course 1 and day 1 of courses 2 and 3
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 2.5 years.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL)
Meets 1 of the following criteria:
Failed ≥ 2 regimens for remission induction
More than 25% blasts in bone marrow aspirate (M3 marrow)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Immunologic
Other
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 4 months since prior stem cell transplantation
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Anne Angiolillo, MD | Childrens Research Institute |
Investigator: | Alice L. Yu, MD, PhD | University of California, San Diego |
Study ID Numbers: | CDR0000378240, COG-ADVL0222, NCI-05-C-0248 |
Study First Received: | August 4, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00089349 |
Health Authority: | United States: Food and Drug Administration |
recurrent childhood acute lymphoblastic leukemia |
Folic Acid Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Alemtuzumab Methotrexate 6-Mercaptopurine Lymphoproliferative Disorders Lymphoma Recurrence |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |