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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia  Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
For Condition: untreated childhood acute lymphoblastic leukemia,B-cell childhood acute lymphoblastic leukemia,L2 childhood acute lymphoblastic leukemia,L1 childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology 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 combining drugs in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.
Details: OBJECTIVES: I. Determine the feasibility of administering a new combination of agents during postinduction consolidation therapy in children with very high risk acute lymphocytic leukemia (VHR-ALL). II. Assess the tolerance of patients in remission of VHR-ALL for postconsolidation therapy with continuous intensification. PROTOCOL OUTLINE: Patients receive induction therapy on weeks 1-4. This consists of oral prednisone three times a day on days 1-28; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV on days 8, 15, and 22; and asparaginase IM on days 2, 5, 8, 12, 15, and 19. Patients also receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS 2 and 3 disease also receive methotrexate IT on days 15 and 22. Patients who achieve M2 bone marrow on day 29 receive oral prednisone three times a day on days 29-42; vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36; and asparaginase IM on days 29, 32, 36, and 39. If bone marrow is M3 on day 29 or M2 or M3 on day 43, then patient is off study. Patients proceed to consolidation therapy on weeks 5-25. This consists of high dose methotrexate IV over 24 hours on weeks 6, 8, 16, and 18, followed by leucovorin calcium IV or orally every 6 hours for 5 doses; oral mercaptopurine on weeks 6-9 and 16-19; cytarabine IV over 6 hours followed by idarubicin IV over 15 minutes for 4 days; and filgrastim (G-CSF) subcutaneously (SQ) beginning on day 5 and continuing for about 10-14 days on weeks 10 and 20. Patients receive etoposide IV over 1 hour followed by cyclophosphamide IV over 10 minutes for 5 days and G-CSF SQ beginning on day 6 for 10-14 days on weeks 13 and 23. Methotrexate IT is administered on weeks 6, 8, 13, 16, 18, and 23. Patients then proceed to continuous intensification therapy during weeks 26-61. Patients receive vincristine IV, daunorubicin IV, and methotrexate IT on day 1, and oral dexamethasone twice a day on days 1-7 on weeks 26, 32, 38, 44, 50, and 56. Patients also receive high dose cytarabine IV over 1 hour, every 12 hours, for 4 doses, followed by asparaginase IM 3 hours after the last dose of cytarabine, on weeks 27, 33, 39, 45, 51, and 57. Oral mercaptopurine and methotrexate IM are administered on day 1 during weeks 29, 31, 35, 37, 41, 43, 47, 49, 53, 55, 59, and 61. Patients receive etoposide IV over 1-2 hours followed by cyclophosphamide IV during weeks 30, 36, 42, 48, 54, and 60. Patients then proceed to continuation therapy during weeks 62-126. Vincristine IV and cyclophosphamide IV are administered on weeks 62-65, 70-73, 78-81, 86-89, 94-97, 102-105, 110-113, and 118-121. Patients also receive oral dexamethasone twice a day for 7 days on weeks 62, 70, 78, 86, 94, 102, 110, and 118, and cytarabine IV on weeks 63, 65, 71, 73, 79, 81, 87, 89, 95, 97, 103, 105, 111, 113, 119, and 121. Oral mercaptopurine is administered daily during weeks 66-69, 74-77, 82-85, 90-93, 98-101, 106-109, 114-117, and 122-125 and methotrexate IM on weeks 66-69, 74-77, 82-85, 90-93, 98-101, 106-109, 114-117, and 122-125. Methotrexate IT is administered during weeks 62, 70, 78, 86, 94, 102, 110, and 118. Patients who are CNS 3 at diagnosis receive whole brain irradiation beginning at week 62 along with the first course of continuation therapy. These patients do not receive any methotrexate IT after week 62. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, then annually thereafter. PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed B-cell precursor acute lymphocytic leukemia; No L3 morphology - Very poor prognosis CNS 3 (blasts and WBC greater than 5 microliters) OR Must meet all of the following criteria: No simultaneous trisomy 4 and 10 DNA index no greater than 1.16 (if FISH 4 and 10 unsatisfactory); No TEL-AML1 [t(12;21)] Meets at least 1 of the following: Has MLL (11q23) and/or BCR-ABL [t(9;22)] WBC greater than 100,000/mm3; Age over 12 (boys) or 16 (girls) OR Boys 8 or Girls 12 with WBC greater than 80,000/mm3; Boys 9 or Girls 13 with WBC greater than 60,000/mm3; Boys 10 or Girls 14 with WBC greater than 40,000/mm3; Boys 11 or Girls 15 with WBC greater than 20,000/mm3 - Concurrent registration on stratum 6 of POG-9400 before 11/15/1999 OR Concurrent registration on stratum 4 of POG-9900 after 11/15/1999; Concurrent registration on POG-9201, POG-9705, or POG-9806 unless ineligible --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: Children - 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:
WilliamBowman, Study Chair, Pediatric Oncology Group
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
St. John's Hospital and Medical Center
Detroit, Michigan, 48236
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
United States
Baptist Hospital of Miami
Miami, Florida, 33176-2197
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Scott and White Clinic
Temple, Texas, 76508
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61602
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Canada
San Jorge Childrens Hospital
Santurce, , 00912
Puerto Rico
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
United States
Maine Children's Cancer Program
Portland, Maine, 04101
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24029
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453
United States
Naval Medical Center - San Diego
San Diego, California, 92134-3202
United States
Clinique de Pediatrie
Geneva, , 1211
Switzerland
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
United States
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22046
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Canada
St. Mary's Hospital
West Palm Beach, Florida, 33407
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
James H. Quillen College of Medicine
Johnson City, Tennessee, 37614-0622
United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9162
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
West Virginia University Medical School, Charleston Division
Charleston, West Virginia, 25304
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Canada
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32803
United States
Additional Information:
Study ID Numbers: CDR0000066915; POG-9806
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003783
Other Untreated Childhood Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
2. Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
3. Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia
4. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
5. Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
Related Studies:
Other untreated childhood acute lymphoblastic leukemia Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
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