Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
Official Title: A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All
Study ID: NCT00005977
Study Description
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 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
Detailed Description: OBJECTIVES: * Determine if increasing the methotrexate dose in combination with standard treatment is feasible in patients with advanced small noncleaved cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia. * Assess the toxicity of this intensified therapy in these patients. * Assess the feasibility of treating these patients that have CNS disease at diagnosis with this intensified therapy plus etoposide and ifosfamide. * Assess toxicities and late effects of this intensive therapy on the central nervous system, cardiac function, and fertility in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to stage and disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL with no CNS involvement vs stage IV NHL with CNS involvement vs B-cell acute lymphocytic leukemia (B-ALL) with no CNS involvement vs B-ALL with CNS involvement). Patients receive methotrexate and cytarabine intrathecally on days 1, 4, 11, and 36 (on day 40 for patients with stage IV NHL or B-ALL only) in combination with alternating courses of: A) cyclophosphamide IV every 12 hours for a total of six doses on days 1-3, doxorubicin IV over 30 minutes on day 4, vincristine IV on days 4 and 11, dexamethasone IV or orally twice daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SQ) or IV over 30 minutes beginning on day 5 and continuing until blood counts recover and B) methotrexate IV over 24 hours on day 18, methotrexate intrathecally on day 18, dexamethasone IV or orally twice daily on days 18-22, leucovorin calcium IV or orally every 6 hours for a total of 6 doses on days 20-21, cytarabine IV over 48 hours on days 20-21, and G-CSF SQ or IV over 30 minutes beginning on day 22 and continuing until blood counts recover. Patients with stage III NHL receive at total of 5 courses of treatment (A-B-A-B-A) and patients with stage IV NHL or B-ALL with no CNS involvement receive a total of 6 courses of treatment (A-B-A-B-A-B). Patients with CNS involvement receive a third course of treatment: C) etoposide IV over 1 hour on days 36-40, ifosfamide IV over 1 hour on days 36-40, oral dexamethasone twice daily on days 36-40, and G-CSF SQ or IV over 30 minutes beginning on day 41 and continuing until blood counts recover. Patients with CNS involvement receive a total of 7 courses of treatment (A-B-C-A-B-A-B). Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 27-80 patients will be accrued for this study over 24 months.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
University of South Alabama Medical Center, Mobile, Alabama, United States
MBCCOP - Gulf Coast, Mobile, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California San Diego Cancer Center, La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford, Palo Alto, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Medical Center, Sacramento, California, United States
Kaiser Permanente-Southern California Permanente Medical Group, San Diego, California, United States
Children's Hospital and Health Center, San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
University of Miami-Jackson Memorial Hospital Medical Center, Miami, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Baptist Hospital of Miami, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
All Children's Hospital, St. Petersburg, Florida, United States
CCOP - Florida Pediatric, Tampa, Florida, United States
St. Mary's Hospital, West Palm Beach, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
Children's Memorial Hospital, Chicago, Chicago, Illinois, United States
Hope Children's Hospital, Oak Lawn, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Maine Children's Cancer Program, Portland, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
St. John Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of New Mexico School of Medicine, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Mission Saint Joseph's Health System, Asheville, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Healthcare, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
East Carolina University School of Medicine, Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
CCOP - Columbia River Program, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, United States
James H. Quillen College of Medicine, Johnson City, Tennessee, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Texas Oncology P.A., Dallas, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, United States
MBCCOP - South Texas Pediatric, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Scott and White Clinic, Temple, Texas, United States
Vermont Cancer Center, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Carilion Roanoke Community Hospital, Roanoke, Virginia, United States
Madigan Army Medical Center, Tacoma, Washington, United States
West Virginia University Medical School-Charleston, Charleston, West Virginia, United States
West Virginia University Hospitals, Morgantown, West Virginia, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Royal Children's Hospital, Parkville, Victoria, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Children's Hospital, Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval, Sainte Foy, Quebec, Canada
Laval University Medical Center, Sainte-Foy, Quebec, Canada
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
San Jorge Childrens Hospital, Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Clinique de Pediatrie, Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Contact Details
Name: Hazem H. Mahmoud, MD
Affiliation: Carol G. Simon Cancer Center at Morristown Memorial Hospital
Role: STUDY_CHAIR
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