PR104 and G-CSF in Treating Patients With Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors|
- Maximum tolerated dose of PR-104 [ Time Frame: 3 weeks (cycle 1) ] [ Designated as safety issue: Yes ]
- Safety profile using CTCAE v3 criteria [ Designated as safety issue: Yes ]
- Dose-limiting toxicity of PR-104 [ Designated as safety issue: Yes ]
- Pharmacokinetics of PR-104 and its alcohol metabolite in blood [ Designated as safety issue: No ]
- Anti-tumor activity [ Designated as safety issue: No ]
- Biomarkers of tumor hypoxia [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616213
|United States, Arizona|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea|
|Scottsdale, Arizona, United States, 85258-4512|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|
|Hamilton, New Zealand, 2020|