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Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia Clinical research trials and Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia  Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
For Condition: stage 1 chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia,stage 2 chronic lymphocytic leukemia,stage 3 chronic lymphocytic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as Campath-1H 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 Campath-1H in treating patients who have chronic lymphocytic leukemia.
Details: 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 Campath-1H (monoclonal antibody CD52) consolidation. II. Determine the infectious toxicities of and feasibility of this regimen in this patient population. III. Determine the progression free and overall survival of these patients on this regimen. IV. Determine the immunologic effects of this treatment in these patients. PROTOCOL OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week every 28 days. Treatment continues 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 Campath-1H IV over 2 hours 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of Campath-1H, followed by 2 more months of observation. Patients are followed every 3 months for the first year, and then every 6 months for the next 8 years. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KantiRai, Study Chair, Cancer and Leukemia Group B
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Additional Information:
Study ID Numbers: CDR0000067506; CLB-19901
Study Start Date: May 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004857
Other Stage 2 Chronic Lymphocytic Leukemia Studies:
1. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
2. Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
3. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
4. Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
5. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other stage 2 chronic lymphocytic leukemia Clinical Trials
Other Missouri Clinical Trials
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Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
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