VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00098761
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain tumors.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose and dose-limiting toxicity of VNP40101M in pediatric patients with recurrent, progressive, or refractory primary brain tumors.
Secondary
* Determine the pharmacokinetics of this drug and its active metabolite VNP4090CE in these patients.
* Determine the efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to receiving ≥ 1 of the following prior therapies: craniospinal irradiation (yes vs no), autologous bone marrow transplant (yes vs no), and \> 2 myelosuppressive chemotherapy or myelosuppressive biologic therapy regimens (yes vs no).
Patients receive VNP40101M IV over 30 minutes on days 1-5. Treatment repeats every 42 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-6 patients per stratum receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 25% of patients experience dose-limiting toxicity. A total of 12 patients are treated at the MTD.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 4-60 patients (2-30 per stratum) will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Estimate the maximum tolerated dose First 6 weeks of therapy Number of participants with dose limiting toxicities First 6 weeks of therapy
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Day 1 of therapy Plasma samples for pharmacokinetic studies will be collected with the first dose of the study drug pre-infusion, and 5, 15, and 30 minutes, 1 hour, 2 hours, and 4 hours after the end of infusion. VNP40101M plasma concentration-time data will be modeled and the individual pharmacokinetic pararmeters volume of the central compartment, elimination rate constant, and half-life will be estimated.
Tumor response to VNP40101M Prior to course 3, 5, and 7 and end of therapy MRI of the brain will be obtained prior to couses 3, 5, and 7 and at the end of therapy
Trial Locations
- Locations (10)
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
🇺🇸Houston, Texas, United States