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Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia Clinical research trials and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia. Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia  Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
For Condition: untreated adult acute lymphoblastic leukemia,L2 adult acute lymphoblastic leukemia,L1 adult acute lymphoblastic 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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.
Details: OBJECTIVES: I. Determine the complete response rate and toxicity of escalating doses of daunorubicin in patients under 60 years old with untreated acute lymphoblastic leukemia (ALL). II. Determine the complete response rate and toxicity of a constant dose of daunorubicin in patients at least 60 years old with untreated ALL. III. Determine the toxicity of high dose cytarabine during postremission therapy in these patients. IV. Determine the CNS relapse rate of ALL when prophylactic intrathecal methotrexate and high dose intravenous chemotherapy replace cranial irradiation. V. Target a serum methotrexate level of between 1-2uM at 30 hours following initiation of IV methotrexate infusion. PROTOCOL OUTLINE: Course I: Patients are assigned to 1 of 2 induction treatment groups based on age: Group 1 (under age 60): Patients receive cyclophosphamide IV over 15-30 minutes on day 1, escalating doses of daunorubicin IV over 5-10 minutes on days 1-3, vincristine IV on days 1, 8, 15, and 22, oral prednisone on days 1-21, asparaginase intramuscularly on days 5, 8, 11, 15, 18, and 22, and filgrastim (G-CSF) subcutaneously (SQ) beginning on day 4 and continuing for at least 7 days and then until blood counts recover. Group 2 (age 60 and over): Patients receive vincristine, asparaginase, cyclophosphamide, and G-CSF as in group 1 and fixed dose daunorubicin IV over 5-10 minutes on days 1-3 and oral prednisone on days 1-7. Patients are then evaluated for bone marrow cellularity on day 29. Those with M0, M1, or M2 cellularity proceed to course II. Patients with M3 cellularity may proceed to course II or be removed from study. Course II (early intensification): Patients receive intrathecal methotrexate and cyclophosphamide IV over 15-30 minutes on day 1, cytarabine IV over 3 hours on days 1-3, and G-CSF SQ beginning on day 4. Bone marrow is again examined on day 29. Patients with M0 or M1 cellularity after course I and no sign of relapse after course II proceed to course III. Patients with M2 or M3 cellularity after course I must have M0 or M1 cellularity after course II to proceed to course III. Patients with M2 or M3 cellularity after course II are removed from study. Course III: Patients receive intrathecal methotrexate, vincristine IV, and methotrexate IV over 3 hours on days 1, 8, and 15 and oral methotrexate every 6 hours for 4 doses beginning 6 hours after starting methotrexate IV on days 1, 2, 8, 9, 15, and 16. Patients receive leucovorin calcium IV 6 hours after the last oral methotrexate dose on days 2, 9, and 16 and oral leucovorin calcium beginning 12 hours after leucovorin calcium IV for at least 4 doses on days 3, 4, 10, 11, 17, and 18. Patients who maintain M0 or M1 cellularity on day 29 of course III continue therapy. Those with M2 or M3 cellularity after course III are removed from the study. Course IV (Late intensification): Repeat course I. Course V (Late intensification): Repeat course II. Course VI (CNS intensification): Repeat course III. Course VII (Prolonged maintenance): Patients receive oral mercaptopurine daily, vincristine IV once every 4 weeks, oral prednisone on days 1-5, and oral methotrexate on days 1, 8, 15, and 22. Courses repeat every 4 weeks for up to 18 months. Patients with testicular disease receive gonadal radiotherapy anytime after course I. Chemotherapy is not halted during radiotherapy. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually for 10 years. PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven acute lymphoblastic leukemia (FAB L1 or L2) or acute undifferentiated leukemia - Must be registered on companion protocol CALGB-9862 --Prior/Concurrent Therapy-- - Biologic therapy: Prior emergency leukapheresis allowed; No other prior biologic therapy for leukemia - Chemotherapy: Prior emergency treatment with hydroxyurea for hyperleukocytosis allowed; No other prior chemotherapy for leukemia; No other concurrent chemotherapy - Endocrine therapy: No prior endocrine therapy for leukemia; No concurrent hormonal therapy (except steroids for adrenal failure or hormones for nondisease related conditions) - Radiotherapy: One prior dose of cranial radiotherapy for CNS leukostasis allowed; No other prior radiotherapy for leukemia; No concurrent palliative radiotherapy except whole brain irradiation for CNS disease - Surgery: Not specified --Patient Characteristics-- - Age: 15 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WendyStock, Study Chair, Cancer and Leukemia Group B
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Cooper Cancer Institute
Camden, New Jersey, 08103
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
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
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Additional Information:
Study ID Numbers: CDR0000066807; CLB-19802
Study Start Date: January 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003700
Other L1 Adult Acute Lymphoblastic Leukemia Studies:
1. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
2. FR901228 in Treating Patients With Hematologic Cancer
3. Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
4. Diagnostic Study of Patients With Acute Lymphoblastic Leukemia
5. Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Related Studies:
Other L1 adult acute lymphoblastic leukemia Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
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