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Brief Title: Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Official Title: Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
Study ID: NCT00096135
Brief Summary: RATIONALE: Drugs used in chemotherapy work in 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 combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.
Detailed Description: OBJECTIVES: Primary * Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse. * Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse. * Determine the toxicity of these regimens in these patients. Secondary * Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens. * Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens. * Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients. * Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients. OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular). * Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin\* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy\*\* (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22. NOTE: \*The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted. NOTE: \*\*Patients with isolated testicular relapse receive ITT on day 1 only. In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy. Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36. * Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover. Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy. * Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT\* on days 15, 36, 57, and 78. NOTE: \*Patients with isolated testicular relapse receive ITT on days 36 and 78 only. * Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15. * Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT\* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover. NOTE: \*Patients with isolated testicular relapse receive ITT on days 22 and 106 only. * Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15. Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions. * Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses. * Maintenance therapy for isolated testicular relapse: * (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses. * (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses. Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients. All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment. Patients are followed for survival.
Minimum Age: 18 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital and Research Center Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States
Sutter Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Broward General Medical Center Cancer Center, Fort Lauderdale, Florida, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Baptist-South Miami Regional Cancer Program, Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Keyser Family Cancer Center at Advocate Hope Children's Hospital, Oak Lawn, Illinois, United States
Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Simmons Cooper Cancer Institute, Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
CancerCare of Maine at Eastern Maine Medical Center, Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Overlook Hospital, Morristown, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Brooklyn Hospital Center, Brooklyn, New York, United States
Maimonides Cancer Center at Maimonides Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Winthrop University Hospital, Mineola, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
Akron Children's Hospital, Akron, Ohio, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's - Dayton, Dayton, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
Tod Children's Hospital, Youngstown, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Hospital Cancer Center, Greenville, South Carolina, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
T.C. Thompson Children's Hospital, Chattanooga, Tennessee, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
University of Alberta Hospital, Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
Starship Children's Health, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne, Lausanne, , Switzerland
Name: Julio C. Barredo, MD
Affiliation: University of Miami Miller School of Medicine-Sylvester Cancer Center
Role: STUDY_CHAIR
Name: Caroline A. Hastings, MD
Affiliation: UCSF Benioff Children's Hospital Oakland
Role: STUDY_CHAIR