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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia  Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
For Condition: L1 childhood acute lymphoblastic leukemia,L2 childhood acute lymphoblastic leukemia,acute undifferentiated leukemia,untreated childhood acute lymphoblastic leukemia
Status: No longer 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. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia. - Determine the event-free survival of patients treated with this regimen. - Determine the clinical prognostic features associated with outcome in these patients. - Compare the biologic characteristics of the leukemia cells with outcome in these patients. OUTLINE: This is a multicenter study. Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14; daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt CNS disease). Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15. Patients who do not receive bone marrow transplantation (BMT) proceed to interim maintenance #1 when blood counts recover. Patients receive methotrexate IT on days 1, 11, 22, and 32; methotrexate IV and vincristine IV on days 1, 11, 22, 32, and 43; and pegaspargase IM on days 2 and 23. When blood counts recover, patients receive delayed intensification #1 comprising vincristine IV on days 1, 8, 15, 43, and 50; doxorubicin IV on days 1, 8, and 15; oral dexamethasone 3 times daily on days 1-7 and 15-21; pegaspargase IM on days 4 and 43; cyclophosphamide IV on day 29; methotrexate IT on days 29 and 36; oral thioguanine on days 29-42; and cytarabine IV or SC on days 30-33 and 37-40. When blood counts recover, patients receive interim maintenance #2 comprising vincristine as in interim maintenance #1; methotrexate IT on day 1 and IV on days 1, 11, 22, 32, and 41; and pegaspargase IM on days 2 and 23. When blood counts recover, patients receive delayed intensification #2 comprising vincristine, doxorubicin, dexamethasone, pegaspargase, cyclophosphamide, cytarabine, and thioguanine as in intensification #1. Patients also receive methotrexate IT on days 1 and 29. When blood counts recover, patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; vincristine IV on days 1, 29, and 57; oral dexamethasone 3 times daily on days 1-5, 29-33, and 57-61; and oral mercaptopurine daily. Treatment repeats every 84 days for 6 courses. Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance #1 and #2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification #1 and #2. After augmented consolidation therapy, patients meeting the following criteria may receive BMT in place of chemotherapy: - In remission - Exhibiting chromosome translocation involving 11q23 or Ph+{(9;22)} - Available HLA-A, B, DR genotypic identical relative donor - No uncontrolled infection - Adequate organ function Within 3-4 weeks of consolidation therapy, patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5; cyclophosphamide IV over 30 minutes on days -7 and -6; and methylprednisolone IV twice daily on days -2 to 0. Patients also undergo total body irradiation twice daily on days -3 to 0. Patients receive allogeneic BMT on day 0. Patients also receive cyclosporine IV every 12 hours beginning on day -1, switching to oral when possible, and continuing until day 60. Patients then taper cyclosporine over the next 60-120 days. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1-2 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 20-40 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia - CNS or testicular disease allowed - No L3 sIg+ ALL or acute myelogenous leukemia - At least 36 weeks gestation for congenital ALL PATIENT CHARACTERISTICS: Age: - Under 366 days at diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar puncture results known - No chronic steroid treatment for other disease Radiotherapy: - Not specified Surgery: - Not specified Other: - No other concurrent cytotoxic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulGaynon, Study Chair, Children's Hospital Los Angeles
Methodist Cancer Center
San Antonio, Texas, 78229-3902
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6006
Australia
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
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
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Australia
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60601
United States
Children's Hospitals and Clinics - Minnesota
St. Paul, Minnesota, 55102
United States
Children's Medical Center - Dayton
Dayton, Ohio, 45404
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Children's Hospital of Denver
Denver, Colorado, 80218-1088
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Deaconess Medical Center
Spokane, Washington, 99210-0248
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Children's Hospital of Oakland
Oakland, California, 94609-1809
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19899
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0914
United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Children's Hospital Central California
Madera, California, 93638-8762
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Additional Information:
Study ID Numbers: CDR0000068787; COG-AALL01P1
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022126
Other L1 Childhood Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
2. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
3. Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
4. Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
5. Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
Related Studies:
Other L1 childhood acute lymphoblastic leukemia Clinical Trials
Other California Clinical Trials
Other Madera Clinical Trials
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
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