Spots Global Cancer Trial Database for Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
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Trial Identification
Brief Title: Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
Official Title: A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study
Study ID: NCT00003370
Interventions
Study Description
Brief Summary: Phase I trial to study the effectiveness of irofulven in treating children with recurrent or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die.
Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of 6-hydroxymethylacylfulvene (MGI-114) in pediatric patients with recurrent or refractory solid tumors. II. Determine the incidence and severity of other toxic effects of MGI-114. III. Determine a safe and tolerable dose of MGI-114 to be used in phase II studies. IV. Determine the pharmacokinetics of MGI-114 in these patients. V. Determine preliminary evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid tumors. OUTLINE: This is a dose escalation study. If the dose limiting toxicity is myelosuppression in stratum 1, then stratum 1 is closed and stratum 2 opens. Stratum 2 consists of the following: patients receiving no more than 2 prior chemotherapy regimens; patients who have not received prior central axis radiation or bone marrow transplantation; and patients with no known bone marrow involvement. Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days. The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed. Patients with stable or responding disease may receive up to 1 year of therapy. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy. Patients are followed until death.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope National Medical Center, Duarte, California, United States
University of California San Diego Cancer Center, La Jolla, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Stanford University Medical Center, Stanford, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Florida Health Science Center, Gainesville, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Children's Memorial Hospital, Chicago, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Columbia Presbyterian Hospital, New York, 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
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States
Children's Hospital of Columbus, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Texas Children's Cancer Center, Houston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Veterans Affairs Medical Center - Huntington, Huntington, West Virginia, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Hospital for Sick Children, Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Contact Details
Name: Gail C. Megason, MD
Affiliation: University of Mississippi Cancer Clinic
Role: STUDY_CHAIR
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