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Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia Clinical research trials and Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia  Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
For Condition: L2 childhood acute lymphoblastic leukemia,L1 childhood acute lymphoblastic leukemia,untreated childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
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 and giving the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
Details: OBJECTIVES: I. Compare the outcomes in children with higher risk acute lymphocytic leukemia (ALL) treated with postinduction chemotherapy based on marrow response on day 7 of induction therapy: for patients with rapid early response (M1/M2), standard vs intensified consolidation chemotherapy and standard vs prolonged duration of intensification chemotherapy; for patients with slow early response, addition of doxorubicin vs idarubicin and cyclophosphamide to intensification chemotherapy. II. Decrease the incidence of avascular necrosis by alternating dexamethasone dosing in patients undergoing 2 courses of delayed intensification. III. Assess the impact of day 7 marrow status on outcome in these patients. IV. Determine prognosis more precisely by supplementing presenting clinical features, immunophenotype, ploidy, cytogenetics, and early marrow response with BAX/BCL-2 ratios, pattern of tyrosine kinase activation, leukemic burden following induction and intensification therapy, and development of high antibody titer to E. coli asparaginase. V. Correlate the traditional prognostic factors of day 7 marrow response, immunophenotype, ploidy, cytogenetics, and early marrow response with BAX/BCL-2 ratios. PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients are stratified by center. Patients receive one course of the VPLD regimen comprised of vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0 and 7, oral prednisone daily on days 0-7, intrathecal cytarabine on day 0, and asparaginase or pegaspargase intramuscularly on days 3, 5, and 7. Patients are assigned to 1 of 2 two postinduction chemotherapy groups based on bone marrow response on day 7 of induction. Patients with M1/M2 marrow on day 7 are considered rapid early responders. Patients with M3 marrow on day 7 are considered slow early responders. Group 1: Rapid early responders Patients receive 2 additional courses of VPLD induction chemotherapy. Patients are then randomized to 1 of 4 treatment arms: Arm I: Beginning on day 35 of induction therapy, patients receive standard Berlin-Frankfurt-Munster (BFM) regimen with standard delayed intensification. Standard BFM for patients in arm I consists of the following: consolidation over 5 weeks with cyclophosphamide, cytarabine, and mercaptopurine; interim maintenance over 8 weeks with oral methotrexate and mercaptopurine (MTX/MP); and delayed intensification over 7 weeks consisting of reinduction with vincristine, doxorubicin, oral dexamethasone, and asparaginase or pegaspargase followed by reconsolidation with cyclophosphamide, thioguanine, and cytarabine. Arm II: Patients receive standard BFM regimen with double delayed intensification. Patients receive therapy similar to those in arm I, but dexamethasone is interrupted for 1 week during delayed intensification and the intensification regimen is repeated, separated by an 8 week interim maintenance course of oral MTX/MP. Arm III: Patients receive augmented BFM regimen with standard delayed intensification. Patients receive 9 weeks of consolidation therapy with 2 courses of vincristine and pegaspargase alternating with the arm I consolidation therapy. Vincristine, intravenous methotrexate, and pegaspargase (the Capizzi I regimen) are substituted for oral MTX/MP in the interim maintenance regimen. Pegaspargase is substituted for asparaginase and two additional doses of vincristine are administered during delayed intensification. Arm IV: Patients receive augmented BFM regimen with double delayed intensification. Patients receive intensified chemotherapy throughout, combining the additional therapy given to patients in arms II and III. Patients receiving augmented BFM regimen receive pegaspargase instead of asparaginase. Patients with CNS disease at diagnosis are treated only on arm IV. Patients who are Philadelphia chromosome positive and do not have a bone marrow donor are nonrandomly assigned to the treatment group for slow early responders. All RER patients receive the same maintenance therapy with vincristine/prednisone and oral MTX/MP. Intrathecal methotrexate is administered periodically throughout protocol treatment. Group 2: Slow early responders Patients receive augmented BFM consolidation therapy and Capizzi I interim maintenance identical to that received by rapid early responders in arm IV. Patients are then randomized to receive double delayed intensification with either idarubicin or doxorubicin and concurrent cyclophosphamide. All patients receive the same maintenance therapy with vincristine/prednisone and oral MTX/MP. Intrathecal MTX is administered periodically throughout protocol treatment. Patients with CNS disease at entry receive craniospinal irradiation daily for 5 consecutive days beginning on day 0 of consolidation therapy. All slow early responders at diagnosis receive cranial irradiation daily for 5 consecutive days during consolidation therapy. Patients with testicular leukemia at diagnosis receive bilateral testicular irradiation daily for 5 consecutive days during consolidation chemotherapy. Groups 1 and 2: Maintenance therapy continues for 2 years for girls or 3 years for boys beyond completion of consolidation therapy. Patients are followed every 4-6 weeks for 1 year, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 1,520 patients will be accrued for this study over 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Acute lymphocytic leukemia (ALL) with M3 bone marrow; No FAB L3 morphology; CNS or overt testicular leukemia at diagnosis allowed - High risk status; 10-21 years old with any white blood count (WBC); 1-9 years old with WBC of 50,000/mm3 or greater --Prior/Concurrent Therapy-- - No prior therapy for ALL except: Emergency therapy for blast crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration - Biologic therapy: Not specified - Chemotherapy: Intrathecal cytarabine or methotrexate allowed at diagnostic lumbar puncture; Induction therapy must begin within 72 hours after intrathecal injection - Endocrine therapy: At least 1-2 months since prior prednisone, for less than 48 hours, for reactive airway disease; Inhalational steroids allowed - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 1 to 21 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Not specified - Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NitaSeibel, Study Chair, Children's Cancer Group
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901-1780
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Denver
Denver, Colorado, 80218
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000064953; CCG-1961
Study Start Date: September 1996
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002812
Other L1 Childhood Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
2. Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
3. Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia
4. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
5. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Related Studies:
Other L1 childhood acute lymphoblastic leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
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