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Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia Clinical research trials and Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia. Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia clinical trial. Subjects often receive the most expert healthcare possible for their Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia  Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
For Condition: untreated childhood acute lymphoblastic leukemia,childhood acute lymphoblastic leukemia in remission,L2 childhood acute lymphoblastic leukemia,L1 childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): 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. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy to the head or intrathecal chemotherapy may prevent cancer cells from spreading to the brain. It is not yet known which treatment regimen is more effective for acute lymphoblastic leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the head or intrathecal chemotherapy plus high dose cytarabine in preventing CNS disease in children who have acute lymphoblastic leukemia.
Details: OBJECTIVES: I. Compare the efficacy and toxicity of cranial radiation vs triple intrathecal chemotherapy plus high dose systemic cytarabine for prophylaxis of CNS disease in children with acute lymphoblastic leukemia. II. Compare the overall survival rates of these patients after these treatments. PROTOCOL OUTLINE: This is a randomized, multicenter study for approved centers in India only. All patients receive induction therapy and then are randomized to one of two treatment arms. Patients assigned to arm I receive high dose cytarabine and no cranial radiation and patients assigned to arm II receive cranial radiation and no high dose cytarabine. Induction 1: Patients receive vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone on days 1-28, triple intrathecal therapy (methotrexate, hydrocortisone, and cytarabine; TIT) on days 1, 8, 15, and 22, asparaginase IM every other day on days 2-20, and daunorubicin IV on days 8, 15, and 29. Patients who achieve remission proceed to randomization. Arm I: Induction 2: Patients receive oral mercaptopurine daily on days 1-7 and 22-28, cytarabine IV over 3 hours every 12 hours for 4 doses on days 1-2 and 22-23, cyclophosphamide IV on days 1 and 22, and TIT on days 8 and 29. Induction 1 is repeated, then patients proceed to consolidation when blood counts have recovered sufficiently. Consolidation: Induction 2 is repeated, then patients proceed to maintenance when blood counts have recovered sufficiently. Maintenance 1: Patients receive vincristine IV and daunorubicin IV on day 1; oral prednisone on days 1-7; asparaginase IM on days 1, 3, 5, and 7; oral methotrexate once a week beginning on day 15 and skipping every 4th week, for a total of 12 weeks; oral mercaptopurine beginning on day 15 for 3 weeks out of 4, for a total of 12 weeks; and TIT on days 1 and 36. Maintenance 2: Patients receive cytarabine IV over 3 hours every 12 hours for 4 doses on days 1-2, cyclophosphamide IV over 30 minutes on day 1, and methotrexate, mercaptopurine, and TIT on days 8 and 36. A total of 6 maintenance courses are administered, alternating maintenance 1 and 2. Arm II: Induction 2: Patients receive oral mercaptopurine daily on days 1-7 and 15-21, cyclophosphamide IV over 30 minutes on days 1 and 15, and intrathecal methotrexate on days 1, 8, 15, and 22. Patients then receive cranial radiation daily on days 4-12. Induction 1 is repeated, then patients proceed to consolidation after blood counts have recovered sufficiently. Consolidation: Patients receive cyclophosphamide IV over 30 minutes on days 1-15, vincristine IV on days 1 and 15, oral mercaptopurine daily on days 1-7 and 15-21, and cytarabine subcutaneously every 12 hours for 6 doses on days 1-3 and 15-17. Patients proceed to maintenance when blood counts recover sufficiently. Maintenance: Same as maintenance 1 in arm I, excluding TIT. A total of 6 courses are administered. All patients are followed monthly for the first 6 months, then every other month for the next 6 months, every 3 months for the next 2 years, every 6 months for the next 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1100 patients (550 per arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/20 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Cytologically confirmed acute lymphoblastic leukemia; Greater than 25% lymphoblasts in bone marrow - No mediastinal or localized lymphoblastic lymphoma; No single node or extranodal site without bone marrow involvement - No B cell lymphoma (Burkitt's or L3 FAB) - No blast cells positive for myeloperoxidase - No CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: No prior corticosteroids - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 1-20 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Not specified - Renal: Not specified - Other: HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanMagrath, Study Chair, National Cancer Institute (NCI)
All-India Institute of Medical Sciences
New Delhi, , 110029
India
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106
United States
Cancer Institute (W.I.A.)
Madras, , 600020
India
Tata Memorial Centre
Mumbai, , 400012
India
Kidwai Memorial Institute of Oncology
Bangalore, , 560029
India
Pediatric Oncology Branch
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: CDR0000066120; NCI-0H98-C-N007,NCI-98-C-N007,MCP943
Study Start Date: June 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019409
Other L2 Childhood Acute Lymphoblastic Leukemia Studies:
1. Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia
2. Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia
3. Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
4. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
5. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Related Studies:
Other L2 childhood acute lymphoblastic leukemia Clinical Trials
Other Clinical Trials
Other New Delhi Clinical Trials
Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
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