Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia
NCT ID: NCT00002816
Last Updated: 2013-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
1996-12-31
2006-04-30
Brief Summary
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PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia.
Detailed Description
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OUTLINE: All patients receive induction chemotherapy over 5 weeks with: etoposide, ifosfamide/mesna, dexamethasone, vincristine, and pegaspargase (if pegaspargase is not available, E. coli asparaginase may be substituted throughout study); then dexamethasone, vincristine, pegaspargase (or E. coli asparaginase), and high-dose methotrexate with leucovorin rescue; and triple intrathecal chemotherapy (TIT). Following induction chemotherapy, all patients receive two 6-week courses of intensification therapy with intermittent TIT; each course consists of dexamethasone, vincristine, high-dose methotrexate/leucovorin, thioguanine, cytarabine, etoposide, and pegaspargase (or E. coli asparaginase) followed by dexamethasone, vincristine, high-dose methotrexate/leucovorin, thioguanine, ifosfamide/mesna, and idarubicin. Patients receive 2 additional courses of intensification chemotherapy followed by four 12-week courses of maintenance chemotherapy with vincristine and methotrexate every 2 weeks and daily oral thioguanine. Total duration of therapy is 78 weeks. Patients with isolated ocular relapse receive local radiotherapy prior to initiation of induction chemotherapy; those who also have CNS leukemia begin TIT with the radiotherapy. Patients with CNS relapse receive craniospinal irradiation during the first month of maintenance therapy, with the dose and fields based on whether they will receive TBI and whether they have had CNS irradiation previously. Patients with testicular relapse receive bilateral testicular irradiation during the first 3 weeks of intensification therapy. Patients are followed every 3 months for 3 years, every 6 months for 3 years, and yearly thereafter, or upon relapse, second malignancy, loss to follow up, or death. All patients undergo quality-of-life assessment at entry and 2 and 4 years after entry.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Study Groups
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EARLY # CNS RELAPSE with BM DONOR
Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, PEG, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, pegaspargase, Ifosfamide with Mesna) and Idarubicin and CXRT.
cytarabine
Given IV
dexamethasone
Given IV
etoposide
Given IV
idarubicin
Given IV
ifosfamide
Given IV
leucovorin calcium
mesna
Given IV
pegaspargase
Given IV
therapeutic hydrocortisone
thioguanine
vincristine sulfate
Given IV
low-LET electron therapy
low-LET photon therapy
Methotrexate
Given IV
LATE CNS RELAPSE with/without BM DONOR, TESTICULAR or OCULAR
Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, pegaspargase, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, PEG, Ifosfamide with Mesna) and Idarubicin), and Maintenance (4 x 12 courses) of ITT, Vincristine, Methotrexate, T-thioguanine.
cytarabine
Given IV
dexamethasone
Given IV
etoposide
Given IV
idarubicin
Given IV
ifosfamide
Given IV
leucovorin calcium
mesna
Given IV
pegaspargase
Given IV
therapeutic hydrocortisone
thioguanine
vincristine sulfate
Given IV
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Methotrexate
Given IV
Interventions
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cytarabine
Given IV
dexamethasone
Given IV
etoposide
Given IV
idarubicin
Given IV
ifosfamide
Given IV
leucovorin calcium
mesna
Given IV
pegaspargase
Given IV
therapeutic hydrocortisone
thioguanine
vincristine sulfate
Given IV
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Methotrexate
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
20 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Michael L.N. Willoughby, MD
Role: STUDY_CHAIR
Princess Margaret Hospital for Children
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Kaplan Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
IWK Grace Health Centre
Halifax, Nova Scotia, Canada
Countries
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References
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Uckun FM, Gaynon PS, Stram DO, Sensel MG, Sarquis MB, Willoughby M. Bone marrow leukemic progenitor cell content in pediatric T-lineage acute lymphoblastic leukemia patients with an isolated extramedullary first relapse. Leuk Lymphoma. 2001 Jan;40(3-4):279-85. doi: 10.3109/10428190109057926.
Uckun FM, Gaynon PS, Stram DO, Sensel MG, Sarquis MB, Lazarus KH, Willoughby M. Paucity of leukemic progenitor cells in the bone marrow of pediatric B-lineage acute lymphoblastic leukemia patients with an isolated extramedullary first relapse. Clin Cancer Res. 1999 Sep;5(9):2415-20.
Other Identifiers
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CCG-1951
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000064968
Identifier Type: OTHER
Identifier Source: secondary_id
1951
Identifier Type: -
Identifier Source: org_study_id