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flt3L in Treating Patients With Acute Myeloid Leukemia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about flt3L in Treating Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. flt3L in Treating Patients With Acute Myeloid Leukemia Clinical research trials and flt3L in Treating Patients With Acute Myeloid Leukemia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like flt3L in Treating Patients With Acute Myeloid Leukemia. flt3L in Treating Patients With Acute Myeloid Leukemia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a flt3L in Treating Patients With Acute Myeloid Leukemia clinical trial. Human subjects often get the best healthcare available for their flt3L in Treating Patients With Acute Myeloid Leukemia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > flt3L in Treating Patients With Acute Myeloid Leukemia  flt3L in Treating Patients With Acute Myeloid Leukemia
flt3L in Treating Patients With Acute Myeloid Leukemia
For Condition: Acute Myeloid Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B,Southwest Oncology Group,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia. PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission.
Details: OBJECTIVES: I. Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone. II. Compare the long-term immunologic effects of these regimens in these patients. III. Compare the long-term safety and toxicity of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within approximately 28 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR): Must be at least 60 years of age if first CR: Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR: Acute myeloblastic leukemia (M0, M1, M2); Acute promyelocytic leukemia (M3); Acute myelomonocytic leukemia (M4;) Acute monocytic leukemia (M5); Acute erythroleukemia (M6); Acute megakaryocytic leukemia (M7;) Refractory anemia with excess blasts in transformation --Prior/Concurrent Therapy-- - Biologic therapy: Prior autologous bone marrow transplantation (BMT) allowed; No prior allogeneic BMT; Other prior immunotherapy allowed if not received during the most recent treatment - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin less than 3 times upper limit of normal (ULN); SGOT less than 3 times ULN - Renal: Creatinine less than 2 mg/dL - Cardiovascular: No clinically significant active cardiac disease - Pulmonary: No clinically significant active pulmonary disease - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No uncontrolled or active autoimmune disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertComis, Study Chair, Eastern Cooperative Oncology Group
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: CDR0000068143; E-2998
Study Start Date: August 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006223
Other Acute Myeloid Leukemia Studies:
1. An open-label, phase II trial of PKC412 monotherapy in patients with acute myeloid leukemia and patients with myelodysplastic syndrome
2. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
3. Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
4. flt3L in Treating Patients With Acute Myeloid Leukemia
5. Phase 2 Study of ZARNESTRA™ as Postconsolidation Therapy for Acute Myeloid Leukemia in Subjects 60 Years & Older
Related Studies:
Other Acute Myeloid Leukemia Clinical Trials
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flt3L in Treating Patients With Acute Myeloid Leukemia
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