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EPO906 Therapy in Patients with Advanced Kidney Cancer



EPO906 Therapy in Patients with Advanced Kidney Cancer

For Condition: Kidney Neoplasms
Status: Suspended
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria The following patients may be eligible for this study: - Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation) - Patients must have had a prior nephrectomy - Must have a life expectancy of greater than three (3) months - Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible. Exclusion Criteria The following patients are not eligible for this study: - Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible - Patients who have had any prior chemotherapy (including a combination therapy) - Patients with symptomatic CNS metastases or leptomeningeal involvement - Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 - Patients with severe cardiac insufficiency - Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports - History of another malignancy within 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ - Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae - HIV+ patients - Pregnant or lactating females.
Total Enrollment: 48

Location and Contact Information:

Our Lady Of Mercy Medical Center
Bronx,  New York,  10466
United States
 

UCLA Medical Center
Los Angeles,  California,  90095
United States
 

University of Washington
Seattle,  Washington,  98109
United States
 

Cleveland Clinic Foundation
Cleveland,  Ohio,  44195
United States
 

Centre L. Berard
Lyon,  , 
France
 

Wayne State University Karmanos Cancer Center
Detroit,  Michigan,  48201
United States
 

University of Maryland
Baltimore,  Maryland,  21201
United States
 

Institut Gustave Roussy
Villejuif,  , 
France
 


Additional Information:
Study ID Numbers:
  CEPO906A-2207; 
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035243

Other Kidney Neoplasms Studies:
1. Advanced Renal Cell Carcinoma

2. Endolymphatic Sac Tumors in a Population of Patients with von Hippel-Lindau Disease:The Natural History and Pathobiology, and a Prospective Non-Randomized Clinical Trial of Hearing Preservation Surgery in Patients with Early Stage Endolymphatic Sac Tumors

3. Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer

4. A Safety, Tolerability and Efficacy Study of E7070 in Patients with Renal Cell Carcinoma

5. A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients with Metastatic Renal Cancer

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