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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004857 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: alemtuzumab Drug: fludarabine phosphate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia |
| Study Start Date: | January 2000 |
OBJECTIVES: I. Determine the overall response rate of previously untreated patients with stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects and feasibility of this regimen in this patient population. III. Determine the treatment-related toxic effects, including infection and injection site reactions, of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine the progression-free and overall survival of patients treated with this regimen. V. Determine the immunologic effects of this regimen in these patients.
OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 year and then every 6 months for 8 years.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Previously untreated, stage I, II, III, or IV B-cell chronic lymphocytic leukemia (CLL) Lymphocytosis greater than 5,000/mm3 with less than 55% prolymphocytes Bone marrow aspirate with greater than 30% of all nucleated cells being lymphoid OR Bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL Overall cellularity must be normocellular or hypercellular Monoclonal B-cell population positive for at least 1 B-lineage marker (CD19, CD20, CD23, CD24) with coexpression of CD5 Bright surface immunoglobulin levels must have CD23 coexpression Stage I or II disease must have evidence of active disease demonstrated by at least 1 of the following: Massive or progressive splenomegaly and/or lymphadenopathy Presence of weight loss greater than 10% over the preceding 6-month period Grade 2 or 3 fatigue Fevers greater than 100.5 degrees Fahrenheit or night sweats for greater than 2 weeks without evidence of infection Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Direct Coomb's test negative Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal Other: Not pregnant or nursing Fertile patients must use effective contraception No medical condition requiring chronic oral corticosteroids
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for CLL No concurrent epoetin alfa Chemotherapy: No prior chemotherapy for CLL No other concurrent chemotherapy Endocrine therapy: No prior corticosteroids for autoimmune complications that have developed since initial diagnosis of CLL No concurrent hormones except steroids for new adrenal failure or nondisease-related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other corticosteroid-based antiemetics Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Veterans Affairs Medical Center - Birmingham | |
| Birmingham, Alabama, United States, 35233-1996 | |
| United States, California | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| University of Illinois at Chicago Health Sciences Center | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at The University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Maine | |
| Veterans Affairs Medical Center - Togus | |
| Togus, Maine, United States, 04330 | |
| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38103 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Vermont | |
| CCOP - Southwestern Vermont Regional Cancer Center | |
| Bennington, Vermont, United States, 05201 | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Veterans Affairs Medical Center - White River Junction | |
| White River Junction, Vermont, United States, 05009 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Veterans Affairs Medical Center - Richmond | |
| Richmond, Virginia, United States, 23249 | |
| Study Chair: | Kanti R. Rai, MD | Long Island Jewish Medical Center |
More Information
| Study ID Numbers: | CDR0000067506, CLB-19901 |
| Study First Received: | March 7, 2000 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004857 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia |
|
Antimetabolites Anti-Infective Agents Vidarabine Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Therapeutic Uses |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Fludarabine monophosphate Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Lymphoproliferative Disorders Leukemia, B-Cell |
