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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00566995 |
Purpose
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 Von Hippel-Lindau syndrome and kidney tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Von Hippel-Lindau Syndrome |
Drug: vandetanib Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
| Official Title: | A Phase II Study of ZD6474 (Vandetanib) in Patients With Von Hippel Lindau Disease and Renal Tumors |
| Estimated Enrollment: | 37 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral vandetanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically during treatment to assess angiogenesis biomarkers such as VEGF, circulating endothelial cells, and circulating endothelial progenitor cells. Samples are analyzed by flow cytometry, real-time RT-PCR, and gene expression.
After completion of study treatment, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least one measurable renal tumor (renal cell carcinoma [RCC]) as defined by RECIST
PATIENT CHARACTERISTICS:
Inclusion criteria:
Measurable QTc and QTc ≤ 480 msec with Bazett's correction by ECG
Exclusion criteria:
History of uncontrolled significant intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| 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 |
More Information
| Responsible Party: | NCI - Urologic Oncology Branch ( William Marston Linehan ) |
| Study ID Numbers: | CDR0000577384, NCI-08-C-0020, NCI-P07148 |
| Study First Received: | December 1, 2007 |
| Last Updated: | July 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00566995 History of Changes |
| Health Authority: | Unspecified |
|
von Hippel-Lindau syndrome recurrent renal cell cancer stage I renal cell cancer |
stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
|
Disease Angiomatosis Neoplasms by Histologic Type Nervous System Diseases Vascular Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma Neoplasms Pathologic Processes Neoplasms by Site |
Urologic Diseases Von Hippel-Lindau Disease Kidney Neoplasms Syndrome Carcinoma, Renal Cell Cardiovascular Diseases Kidney Diseases Adenocarcinoma Neurocutaneous Syndromes Neoplasms, Glandular and Epithelial |