Vandetanib and Temozolomide in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00601614
- Lead Sponsor
- Mayo Clinic
- Brief Summary
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and temozolomide in treating patients with advanced solid tumors that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
* To determine the maximum tolerated dose of concurrently administered vandetanib and temozolomide in patients with unresectable, advanced solid tumors.
* To describe the toxicity profile of this regimen in these patients.
* To describe the response rate in patients treated with this regimen.
* To describe the effects of therapy on angiogenesis-related translational endpoints.
OUTLINE: Patients receive escalating doses of oral vandetanib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and prior to each treatment course for correlative laboratory studies, including evaluation of plasma VEGF levels by ELISA, serum angiogenesis assay, and measurement of circulating endothelial cell populations (CD133, CD34, CD146). Frozen serum and plasma samples are also stored for future research studies.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of vandetanib and temozolomide Adverse events profile Toxicity profile Response profile Time until any treatment-related toxicity Time until treatment-related grade 3+ toxicity Time until hematologic nadirs Time to progression Time to treatment failure Correlation of changes in VEGF levels, serum angiogenesis, and circulating endothelial cells with response and dose levels
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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