An Open-Label, Fixed-Dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma
Approximately 31,000 new cases of renal cell carcinoma (RCC) occur each year in the United
States, with a death rate of about 11,600 annually. Many patients present with advanced or
unresectable disease, and up to 30% of patients who are treated with nephrectomy will
relapse. The 5 year survival rate for metastatic renal RCC is estimated at < 10%. Surgical
resection of discernible disease is the only potentially curative treatment. No significant
improvement in survival has been demonstrated for patients with metastatic RCC who have been
treated with systemic hormonal, chemotherapeutic, and radiation therapy. Interferon alpha
has about a 15% objective response rate in appropriately selected patients. Administration
of interleukin 2 (IL 2) has shown a similar response rate; however, approximately 5% of
highly selected patients had durable complete remissions.
Recent studies demonstrated that RCC cells harbor abnormalities of the von Hippel-Lindau
(VHL) gene, playing a key role in the stimulation of angiogenesis by vascular endothelial
growth factor (VEGF) in this highly vascularized tumor. The novel agents sunitinib (Sutent)
and sorafenib (Nexavar) are approved by the US Food and Drug Administration (FDA) for the
treatment of advanced RCC, and both bevacizumab (Avastin) and temsirolimus have shown
significant activity in treatment-naïve patients. Prolonged progression-free survival has
been reported with sorafenib and sunitinib in randomized, controlled phase 2 and 3 studies,
and improved survival has been reported with temsirolimus in poor-risk patients in a phase 3
randomized study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response
6 months
No
John H Gordon, PhD
Study Director
Cleveland BioLabs
United States: Food and Drug Administration
CBL-DD-07-C-H-2002
NCT00574483
November 2007
January 2008
Name | Location |
---|---|
Community Care Physicians | Albany, New York 12208 |
ClinWorks Cancer Research Center | Charlotte, North Carolina 28207 |