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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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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