Vandetanib and Bevacizumab in Treating Patients With Advanced Solid Tumors or Lymphoma

Phase 1

Completed

• Conditions: Lung Cancer; Lymphoma; Lymphoproliferative Disorder; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00734890
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

RATIONALE: Vandetanib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving vandetanib together with bevacizumab may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and bevacizumab in treating patients with advanced solid tumors or lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose, safety, and toxicity of vandetanib and bevacizumab in patients with advanced solid tumors or lymphoma.

Secondary

* Characterize the pharmacokinetic profile of this regimen in these patients.

* Measure changes in VEGF and other angiogenic cytokines in plasma samples from these patients.

* Determine the biochemical changes in the EGF signal transduction pathways in tumor biopsy samples from these patients.

* Determine the anti-angiogenic effects of this regimen in tumor biopsy samples from these patients.

* Evaluate the application of dynamic contrast-enhanced MRI to determine early changes in tumor vascular permeability during treatment.

* Evaluate the effects of this regimen on circulating endothelial progenitors and mature circulating endothelial cells in these patients.

OUTLINE: Patients receive oral vandetanib once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative laboratory studies, including pharmacokinetic, biomarker (VEGF and other angiogenic cytokines), and circulating endothelial cell analysis. Patients may also undergo optional tumor biopsies for additional correlative laboratory studies.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2010-06
• Study Completion: 2011-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose
Safety
Toxicity

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States