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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390052 |
RATIONALE: 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of 3-AP in treating patients with advanced or metastatic solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: triapine Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Title: A Phase 1 and Pharmacokinetic Study of Oral 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine®) in the Treatment of Advanced Solid Tumors |
Estimated Enrollment: | 24 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive a one time dose of 3-AP IV over 2 hours on day -7. Patients then receive oral 3-AP twice daily on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oral 3-AP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Blood samples for pharmacokinetic analysis are collected periodically over 8 hours after the IV dose of 3-AP and after the first oral dose of 3-AP during course 1.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
No known active CNS metastases
PATIENT CHARACTERISTICS:
No active heart disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
City of Hope Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
Contra Costa Regional Medical Center | Recruiting |
Martinez, California, United States, 94553 | |
Contact: David R. Gandara, MD 925-372-2064 | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 |
Study ID Numbers: | CDR0000507731, CCC-PHI-52, CHNMC-PHI-52 |
Study First Received: | October 18, 2006 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00390052 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |