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Sponsored by: |
Proacta, Incorporated |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00616213 |
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 | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Biological: filgrastim Drug: PR-104 Other: 18F-fluoromisonidazole Other: imaging biomarker analysis Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given With Prophylactic G-CSF in Subjects With Solid Tumors |
Estimated Enrollment: | 21 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:
PRIOR CONCURRENT THERAPY:
No more than 3 prior myelosuppressive chemotherapy regimens
Patients who have received more than 3 prior myelosuppressive regimens may be eligible, if considered to have adequate marrow, based on prior exposure to 1 of the following regimens:
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 | |
New Zealand | |
Waikato Hospital | |
Hamilton, New Zealand, 2020 |
Investigator: | Kim Smith | Proacta, Incorporated |
Study ID Numbers: | CDR0000584658, PROACTA-PR-104-1004 |
Study First Received: | February 14, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00616213 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |
Radiation-Sensitizing Agents Ro 07-0741 |
Radiation-Sensitizing Agents Ro 07-0741 Physiological Effects of Drugs Pharmacologic Actions |