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Sponsored by: |
Cleveland BioLabs |
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Information provided by: | Cleveland BioLabs |
ClinicalTrials.gov Identifier: | NCT00574483 |
The overall response to standard therapies and to the newer antiangiogenesis therapies is not curative, and treatment-associated toxicities may be severe. Therefore, continued evaluation of therapies, with different mechanisms of action, is needed for patients with metastatic RCC.
Condition | Intervention | Phase |
---|---|---|
Renal Cell Carcinoma |
Drug: quinacrine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label, Fixed-Dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma |
Estimated Enrollment: | 24 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | January 2008 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Unblinded treatment arm
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Drug: quinacrine
100 mg day
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have:
Exclusion Criteria:
Cognex).
United States, New York | |
Community Care Physicians | |
Albany, New York, United States, 12208 | |
United States, North Carolina | |
ClinWorks Cancer Research Center | |
Charlotte, North Carolina, United States, 28207 |
Study Director: | John H Gordon, PhD | Cleveland BioLabs |
Responsible Party: | Cleveland BioLabs, Inc ( John H. Gordon ) |
Study ID Numbers: | CBL-DD-07-C-H-2002 |
Study First Received: | December 13, 2007 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00574483 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Renal cell carcinoma |
Anti-Infective Agents Urinary Tract Neoplasm Kidney Cancer Anthelmintics Urogenital Neoplasms Urologic Neoplasms Carcinoma Antimalarials |
Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Quinacrine Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Urologic Neoplasms Antimalarials Antiparasitic Agents Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Kidney Diseases |
Quinacrine Antinematodal Agents Neoplasms by Histologic Type Antiplatyhelmintic Agents Anthelmintics Enzyme Inhibitors Pharmacologic Actions Carcinoma Anticestodal Agents Neoplasms Carcinoma, Renal Cell Adenocarcinoma Neoplasms, Glandular and Epithelial |