PR104 and G-CSF in Treating Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00616213|
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : June 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: filgrastim Drug: PR104 Other: F-18-fluoromisonidazole||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||June 2009|
- Biological: filgrastim
filgrastim will be administered at a standard dose and scheduleOther Names:
- Drug: PR104
PR104 is administered intravenously once every 21 daysOther Name: PR-104
- Other: F-18-fluoromisonidazole
F-18-fluoromisonidazole is administered intravenously prior to performance of PET scanOther Name: FMISO
- Maximum tolerated dose of PR-104 [ Time Frame: 3 weeks (cycle 1) ]
- Safety profile using CTCAE v3 criteria
- Dose-limiting toxicity of PR-104
- Pharmacokinetics of PR-104 and its alcohol metabolite in blood
- Anti-tumor activity
- Biomarkers of tumor hypoxia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|