PR104 and G-CSF in Treating Patients With Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00616213
- Lead Sponsor
- Proacta, Incorporated
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors.
Secondary
* Characterize the safety of this regimen in these patients.
* Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.
* Evaluate the rate of hypoxia in various solid tumors using F-MISO PET (18F-fluoromisonidazole positron emission tomography) imaging.
* Assess for antitumor toxicity in these patients.
* Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter, dose-escalation study of PR-104.
Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to assess tumor hypoxia.
Patients undergo blood sample collection periodically during course 1. Samples are analyzed for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.
After completion of study treatment, patients are followed at 30 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of PR-104 3 weeks (cycle 1)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of PR-104 and its alcohol metabolite in blood Anti-tumor activity Biomarkers of tumor hypoxia Dose-limiting toxicity of PR-104 Safety profile using CTCAE v3 criteria
Trial Locations
- Locations (3)
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
🇺🇸Scottsdale, Arizona, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
Waikato Hospital
🇳🇿Hamilton, New Zealand