GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT01147029
- Lead Sponsor
- Cancer Research UK
- Brief Summary
RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating patients with advanced solid tumors that have not responded to therapy.
- Detailed Description
OBJECTIVES:
Primary
* To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors.
* To assess the safety and toxicity profile and dose-limiting toxicity of this drug in these patients.
Secondary
* To determine the pharmacokinetics of this drug in these patients.
* To determine the pharmacodynamics of this drug in these patients.
* To determine possible anti-tumor activity in patients treatment with this drug.
Tertiary
* To further determine the pharmacodynamics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive angiogenesis inhibitor GSAO IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients showing clinical benefit (i.e., stable disease, partial response, or complete response) may receive 6 additional courses of treatment. Patients receive angiogenesis inhibitor GSAO IV over 1 hour on day -7 to obtain pharmacokinetics information of a single IV dose of the drug.
Patients also undergo dynamic contrast-enhanced magnetic-resonance imaging (DCE-MRI) prior to, during, and after study to determine blood flow parameters.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and biomarker studies.
After completion of study treatment, patients are followed up for 28 days and then once a month thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0
- Secondary Outcome Measures
Name Time Method Relationship between pharmacokinetics and toxicity and/or markers of efficacy Changes in microvascular function using DCE-MRI Plasma and tumor levels of angiogenic factors and apoptosis markers Response (stable disease, partial response, or complete response) as determined by RECIST criteria Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis
Trial Locations
- Locations (2)
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Churchill Hospital
🇬🇧Oxford, England, United Kingdom