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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00608114 |
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.
PURPOSE: This phase II trial is studying how well vandetanib works in treating patients with unresectable or metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: vandetanib Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: flow cytometry Procedure: gene expression profiling Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Study of ZD6474 (Vandetanib) in Subjects With Advanced Clear Cell Renal Carcinoma |
Estimated Enrollment: | 37 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral vandetanib once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline, 24 hours after the first dose of study drug, and at the end of courses 1 and 2 to measure tumor vascular flow and permeability. Blood is collected at weeks 1 and 3 of course 1, at the beginning of course 2 and each subsequent course, and then at the completion of study treatment. Samples are analyzed by immunohistochemistry to evaluate the effect of vandetanib on tumor microvessel density, proliferation and apoptosis; RT-PCR for transcriptional targets affected by EGFR and VEGF signaling pathways, including p27, KIP1, E-cadherin, and b-catenin; cDNA arrays to compare gene expression profiles in tumor cells before and during treatment with vandetanib; and flow cytometry for evaluation of basal plasma levels of angiogenesis biomarkers such as VEGF. HIF, EGFR, and VEGFR2 expression may be performed on available resected primary tumors to explore the correlation between these biomarkers and clinical response.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed clear cell renal cell carcinoma
Must have received prior sunitinib or sorafenib (discontinued for disease progression or unacceptable toxicity) OR be ineligible to receive sunitinib or sorafenib
PATIENT CHARACTERISTICS:
Calcium (ionized calcium or adjusted for albumin) and magnesium concentrations normal
No clinically significant cardiac event within the past 3 months, including any of the following:
No history of clinically significant cardiac arrhythmia that is symptomatic or requires treatment (CTCAE grade 3), including any of the following:
No QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG OR > 480 msec on average of 3 ECGs taken 24 hours apart
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | William M. Linehan, MD | NCI - Urologic Oncology Branch |
Study ID Numbers: | CDR0000586042, NCI-08-C-0039, NCI-P07217 |
Study First Received: | January 26, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00608114 |
Health Authority: | Unspecified |
clear cell renal cell carcinoma recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |