|
Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia Clinical research trials and Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia  Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
For Condition: recurrent childhood acute lymphoblastic leukemia,L2 childhood acute lymphoblastic leukemia,non-T, non-B childhood acute lymphoblastic leukemia,T-cell childhood acute lymphoblastic leukemia,L1 childhood acute lymphoblastic leukemia
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells. PURPOSE: Randomizedphase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsedacute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the feasibility and safety of an intensified sequential induction regimen in children with an initial bone marrow relapse of acute lymphoblastic leukemia. - Determine the remission reinduction rates and 4-month event-free survival of patients treated with this regimen. - Determine the feasibility of combining this regimen with imatinib mesylate in these patients. - Correlate post-remission events with disease burden during induction in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk (high-vs low), Philadelphia chromosome (Ph) status (negative vs positive), CNS relapse (yes vs no), and duration of first complete remission (less than 36 months vs at least 36 months). Patients without CNS relapse are randomized to arms I or IIa. Patients with CNS relapse are assigned to arm IIb. - The following strata are used: - Stratum 1.1: High risk, Ph negative, with or without non-CNS extramedullary site relapse - Stratum 1.2: High risk, Ph negative, CNS combined relapse - Stratum 1.3:High risk, Ph positive, with or without non-CNS extramedullary site relapse - Stratum 1.4: High risk, Ph positive, CNS combined relapse - Stratum 2.1: Low risk, Ph negative, with or without non-CNS extramedullary site relapse - Stratum 2.2: Low risk, Ph negative, CNS combined relapse - Stratum 2.3: Low risk, Ph positive, with or without non-CNS extramedullary site relapse - Stratum 2.4: Low risk, Ph positive, CNS combined relapse - Treatment Block 1: Patients receive cytarabine intrathecally (IT) on day 1 and methotrexate IT on days 15 and 29. Patients also receive vincristine IV on days 1, 8, 15, and 22; oral prednisone twice or thrice daily on days 1-29; pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22; and doxorubicin IV over 15 minutes on day 1. Ph-positive patients also receive oral imatinib mesylate on days 1-14. - Treatment Block 2: Patients receive methotrexate IT on days 1 and 22, cyclophosphamide IV over 30 minutes and etoposide IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover. Patients also receive methotrexate IV over 24 hours on day 22 followed by leucovorin calcium IV every 6 hours on days 24 and 25. Ph-positive patients receive oral imatinib mesylate on days 1-14. - Treatment Block 3a (Ph-negative patients): Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, asparaginase IM on days 2 and 9, and G-CSF SC beginning on day 10 and continuing until blood counts recover. - Treatment Block 3b (Ph-positive patients): Patients receive cytarabine IV over 3 hours every 12 hours on days 1 and 2, asparaginase IM on day 2, and G-CSF SC beginning on day 3 and continuing until blood counts recover. Patients also receive oral imatinib mesylate on days 1-14. - Arm IIa (Strata 1.1, 1.3, 2.1, and 2.3 only): Patients receive therapy as in arm I except in the following order: block 1, block 3, and block 2. - Treatment Block 1: Patients receive cytarabine IT on day 1 and then methotrexate, cytarabine and hydrocortisone IT (triple intrathecal therapy; TIT) on days 8, 15, 22, and 29. Vincristine, prednisone, pegaspargase, doxorubicin, and imatinib mesylate are administered as in arm I. - Treatment Block 3: Patients receive cytarabine, asparaginase, G-CSF, and imatinib mesylate as in arm I. - Patients receive TIT on days 1 and 22. Patients then receive cyclophosphamide, etoposide, G-CSF, methotrexate IV, leucovorin calcium, and imatinib mesylate as in arm I. After each block is completed, disease is assessed. The next block is started on day 36 if blood counts have recovered and marrow during block 1 is at least M2/M3. Patients are removed from protocol therapy if disease progresses, unacceptable toxicity occurs, marrow is M2/M3 at day 15 of the second administered block of treatment, or cerebrospinal fluid blasts persist after 6 weekly doses of TIT. Patients are followed for at least 4 months. PROJECTED ACCRUAL: A total of 63-126 patients will be accrued for this study within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow) - Philadelphia chromosome-positive patients eligible with or without extramedullary disease - No prior isolated extramedullary relapse - No B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) - No Down syndrome PATIENT CHARACTERISTICS: Age - 1 to 21 at time of relapse Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - Shortening fraction at least 28% by echocardiogram - Ejection fraction at least 50% by MUGA Other - No active fungal infection - No prior invasive filamentous fungal infection - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 12 months since prior stem cell transplantation - No other concurrent immunomodulating agents Chemotherapy - Prior cumulative anthracycline exposure no greater than 350 mg/m^2 - No other concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No other concurrent cytotoxic therapy - No concurrent immunosuppressive therapy for graft-vs-host disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElizabethRaetz, Study Chair, Mount Sinai Medical Center
Children's Hospitals and Clinics - Minnesota *Recruiting*
St. Paul, Minnesota, 55102
United States
Recruiting Christopher Moertel 651-220-6732
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting C. Steuber 713-770-4200
Kaiser Permanente Medical Center - San Francisco Geary Campus *Recruiting*
San Francisco, California, 94115
United States
Recruiting Kenneth Leung 415-833-3528
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Nita Seibel 202-884-2144
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Wei-Ping Shen 714-532-8636
Southern Illinois University School of Medicine *Recruiting*
Springfield, Illinois, 62794-9658
United States
Recruiting Gregory Brandt 217-545-5817
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Daniel McMahon 704-355-1130
Children's Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45404
United States
Recruiting Emmett Broxson 937-641-3111
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Barbara Asselin 716-275-2981
Children's Hospital at O.U. Medical Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting William Meyer 405-271-5437
Childhood Hematology/Oncology Associates *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Edward Arenson 303-832-2462
Kaiser Permanente Medical Center - Santa Clara *Recruiting*
Santa Clara, California, 95051-5386
United States
Recruiting Carolyn Russo 408-236-5028
Presbyterian Healthcare *Recruiting*
Charlotte, North Carolina, 28233
United States
Recruiting Mark Mogul 704-384-1900
Children's Hospital of Greenville Hospital System *Recruiting*
Greenville, South Carolina, 29605
United States
Recruiting Cary Stroud 864-455-8898
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting E. Edwards 202-782-9449
Women's and Children's Hospital *Recruiting*
North Adelaide, South Australia, 5006
Australia
Recruiting Maria Kirby 61-8-8161-7411
Loma Linda University Cancer Institute at Loma Linda University Medical Center *Recruiting*
Loma Linda, California, 92354
United States
Recruiting Antranik Bedros 909-558-3391
IWK Health Centre *Recruiting*
Halifax, Nova Scotia, B3J 3G9
Canada
Recruiting Dorothy Barnard 902-470-8291
Royal Children's Hospital *Recruiting*
Parkville, Victoria, 3052
Australia
Recruiting David Ashley 61-39-345-5522
Cook Children's Medical Center - Fort Worth *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Timothy Griffin 682-885-4020
Princess Margaret Hospital for Children *Recruiting*
Perth, Western Australia, 6001
Australia
Recruiting David Baker 61-8-9340-8234
Phoenix Children's Hospital *Recruiting*
Phoenix, Arizona, 85016
United States
Recruiting Dale Singer 602-546-0920
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Katherine Matthay 415-353-9510
St. Vincent Hospital *Recruiting*
Green Bay, Wisconsin, 54307-9070
United States
Recruiting Jon Brandt 920-433-8670
Deaconess Medical Center *Recruiting*
Spokane, Washington, 99210-0248
United States
Recruiting Steven Bergstrom 509-473-7012
Additional Information:
Study ID Numbers: CDR0000258120; COG-AALL01P2
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049569
Other L2 Childhood Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Related Studies:
Other L2 childhood acute lymphoblastic leukemia Clinical Trials
Other Western Australia Clinical Trials
Other Perth Clinical Trials
Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
|
|
|
|
|
|
|
|
