Spots Global Cancer Trial Database for Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma
Official Title: Vincristine, Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine
Study ID: NCT00003625
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma.
Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of vincristine given as an IV push dose in combination with continuous infusion cyclosporine and oral etoposide concurrent with and prior to radiotherapy in children with newly diagnosed primary intrinsic brain stem glioma. II. Determine the incidence and severity of other toxicities of vincristine in this regimen in these patients. III. Determine a safe and tolerable dose of vincristine under these conditions to be used in phase II studies. IV. Seek preliminary evidence of antitumor activity in this setting in these patients. OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion. Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity (DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12 patients per year.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, 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
Kaiser Permanente-Southern California Permanente Medical Group, San Diego, California, United States
Naval Medical Center - San Diego, San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Baptist Hospital of Miami, Miami, Florida, United States
Walt Disney Memorial Cancer Institute, Orlando, Florida, United States
St. Mary's Hospital, West Palm Beach, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, 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
Christ Hospital, Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Via Christi Regional Medical Center-Saint Francis Campus, Wichita, Kansas, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Maine Children's Cancer Program, Portland, Maine, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Floating Hospital for Children, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
St. John's 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
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
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
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Oklahoma Memorial Hospital, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
Medical University of South Carolina, Charleston, 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
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
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
Inova Fairfax Hospital, Falls Church, Virginia, United States
Carilion Roanoke Memorial Hospital, Roanoke, Virginia, United States
Madigan Army Medical Center, Tacoma, Washington, United States
West Virginia University Medical School, Charleston Division, 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
Alberta Children's Hospital, Calgary, Alberta, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval, Sainte Foy, Quebec, Canada
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
San Jorge Childrens Hospital, Santurce, , Puerto Rico
Clinique de Pediatrie, Geneva, , Switzerland
Contact Details
Name: Mark L. Greenberg, MD
Affiliation: The Hospital for Sick Children
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
