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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00262925 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: alemtuzumab Drug: asparaginase Drug: dexamethasone Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of MOAD (Methotrexate, Vincristine, L-Asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL) |
Estimated Enrollment: | 85 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed periodically for 5 years from the date of registration to this study.
PROJECTED ACCRUAL: Approximately 85 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Refractory or relapsed acute lymphoblastic leukemia
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Study Chair: | Peter H. Wiernik, MD | Our Lady of Mercy Medical Center Comprehensive Cancer Center |
Investigator: | Jeffrey E. Lancet, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000450765, ECOG-E1904 |
Study First Received: | December 6, 2005 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00262925 |
Health Authority: | United States: Federal Government |
recurrent adult acute lymphoblastic leukemia |
Dexamethasone Asparaginase Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Vincristine Leucovorin 6-Mercaptopurine Recurrence Acute lymphoblastic leukemia, adult |
Folic Acid Calcium, Dietary Leukemia Lymphatic Diseases Alemtuzumab Methotrexate Lymphoproliferative Disorders Lymphoma Dexamethasone acetate |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Hormones Vitamins Therapeutic Uses Abortifacient Agents Micronutrients |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Glucocorticoids |