Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT00003783
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Complete Response and CNS 3 filgrastim See detailed description. Complete Response and CNS 3 prednisone See detailed description. Complete Response and CNS 3 vincristine sulfate See detailed description. Complete Response and CNS 3 radiation therapy See detailed description. Complete Response and no CNS 3 filgrastim See detailed description. Complete Response and no CNS 3 daunorubicin hydrochloride See detailed description. Complete Response and no CNS 3 leucovorin calcium See detailed description. Complete Response and no CNS 3 vincristine sulfate See detailed description. Complete Response and no CNS 3 radiation therapy See detailed description. Complete Response and CNS 3 cytarabine See detailed description. Complete Response and CNS 3 daunorubicin hydrochloride See detailed description. Complete Response and CNS 3 leucovorin calcium See detailed description. Complete Response and no CNS 3 asparaginase See detailed description. Complete Response and no CNS 3 dexamethasone See detailed description. Complete Response and no CNS 3 cyclophosphamide See detailed description. Complete Response and no CNS 3 cytarabine See detailed description. Complete Response and no CNS 3 etoposide See detailed description. Complete Response and no CNS 3 idarubicin See detailed description. Complete Response and no CNS 3 mercaptopurine See detailed description. Complete Response and no CNS 3 methotrexate See detailed description. Complete Response and no CNS 3 prednisone See detailed description. Complete Response and CNS 3 asparaginase See detailed description. Complete Response and CNS 3 cyclophosphamide See detailed description. Complete Response and CNS 3 dexamethasone See detailed description. Complete Response and CNS 3 etoposide See detailed description. Complete Response and CNS 3 idarubicin See detailed description. Complete Response and CNS 3 mercaptopurine See detailed description. Complete Response and CNS 3 methotrexate See detailed description.
- Primary Outcome Measures
Name Time Method Assess the feasibility of delivering a new combination of agents during a 20 week post-induction consolidation phase 20 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
West Virginia University Medical School, Charleston Division
🇺🇸Charleston, West Virginia, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Maine Children's Cancer Program
🇺🇸Portland, Maine, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
University of Missouri-Columbia Hospital and Clinics
🇺🇸Columbia, Missouri, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
University of New Mexico School of Medicine
🇺🇸Albuquerque, New Mexico, United States
James H. Quillen College of Medicine
🇺🇸Johnson City, Tennessee, United States
Centre Hospitalier de L'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
St. John's Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Oklahoma Memorial Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Scott and White Clinic
🇺🇸Temple, Texas, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Carilion Roanoke Community Hospital
🇺🇸Roanoke, Virginia, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Clinique de Pediatrie
🇨ðŸ‡Geneva, Switzerland
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Walt Disney Memorial Cancer Institute
🇺🇸Orlando, Florida, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States