Spots Global Cancer Trial Database for Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
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Trial Identification
Brief Title: Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
Official Title: A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
Study ID: NCT00003288
Study Description
Brief Summary: Phase I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors. II. Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients. III. Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications. IV. Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide. V. Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide. OUTLINE: This is a dose escalation study. Patients receive tirapazamine by 2 hour intravenous infusion (hours 0-2) followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide. This course is repeated every 3 weeks in patients with partial/complete response or stable disease for a maximum of 1 year. Cohorts of 3-6 patients each are treated at each dose level of tirapazamine. Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity (DLT). If DLT is experienced in 1 of 3 patients at a given dose level, up to 3 additional patients are treated at that same dose level. If none of the 3 additional patients at that dose level experiences DLT, the dose is escalated. If DLT is experienced in 1 or more of the additional 3 patients, the maximum tolerated dose (MTD) has been exceeded and 3 patients are treated at the next lower dose level (defined as the MTD). A total of six patients are treated at the MTD. If DLT is proved to be neutropenia, patients must then also meet the additional eligibility criteria listed for stratum 2. If neutropenia continues to be the DLT in stratum 2, then additional patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning 24 hours after cyclophosphamide. A second MTD may be determined for chemotherapy with G-CSF. Patients are followed every 6 months for 4 years, and then annually thereafter.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, 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
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Children's Memorial Hospital, Chicago, Chicago, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Floating Hospital for Children, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, 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
Roswell Park Cancer Institute, Buffalo, 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
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Contact Details
Name: Victor Aquino, MD
Affiliation: Simmons Cancer Center
Role: STUDY_CHAIR
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