Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
NCT ID: NCT00003288
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
1998-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
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filgrastim
cyclophosphamide
tirapazamine
Interventions
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filgrastim
cyclophosphamide
tirapazamine
Eligibility Criteria
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Inclusion Criteria
* No leukemia Stratum 2
* No marrow involvement
PATIENT CHARACTERISTICS:
* Age: 21 and under
* Performance status: Karnofsky or Lansky 50-100%
* Life expectancy: At least 8 weeks
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 75,000/mm3
* Hemoglobin at least 9 g/dL
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times normal
* Creatinine normal for age OR creatinine clearance at least 70 mL/min
* Shortening fraction at least 27% of normal OR ejection fraction greater than 50% of normal
* Not pregnant or nursing
* Negative pregnancy test required
PRIOR CONCURRENT THERAPY:
* No concurrent anticancer therapy
* At least 6 months since bone marrow transplant and no evidence of graft versus host disease
* At least 1 week since growth factors
* No concurrent granulocyte colony-stimulating factor
* Recovered from prior immunotherapy
* Stratum 2: No prior bone marrow transplantation (with or without total body irradiation)
* At least 6 weeks since prior nitrosourea
* At least 2 weeks since other prior myelosuppressive chemotherapy
* Dexamethasone must be a stable or decreasing dose for 2 weeks prior to study
* Recovered from prior chemotherapy
* Stratum 2: No more than 2 prior chemotherapy regimens
* At least 2 weeks since local palliative radiotherapy (small port)
* At least 6 months since prior substantial bone marrow radiation (e.g., cross- sectional radiotherapy \[greater than 24 Gy\], total body irradiation, hemi- pelvic radiotherapy)
* Recovered from prior radiotherapy
* Stratum 2: No prior central axis radiation
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Victor Aquino, MD
Role: STUDY_CHAIR
Simmons Cancer Center
Locations
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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
St Louis, Missouri, United States
Washington University School of Medicine
St 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
Countries
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Other Identifiers
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POG-9675
Identifier Type: -
Identifier Source: secondary_id
CDR0000066219
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-01837
Identifier Type: -
Identifier Source: org_study_id
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