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Spots Global Cancer Trial Database for Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

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Trial Identification

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

Conditions

Leukemia

Study Description

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.

Eligibility

Minimum Age: 18 Months

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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