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Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma Clinical research trials and Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma. Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma  Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma
Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma
For Condition: Carcinoma, Renal Cell
Status: Recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: A subject will be eligible for study participation if all of the following criteria are met: 1. The subject is at least 18 years of age. 2. The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection. 3. The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day 1. 4. The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 5. The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections. 6. The subject must have adequate bone marrow, renal, and hepatic function as follows: - Bone Marrow: White blood cell count (WBC) 3,000/mm3 (3.0 X 109/L); Platelets 100,000/mm3 (100 X 109/L); Hemoglobin 9.0 g/dL (1.4 mmol/L) - Renal function: serum creatinine 2.0 mg/dL (0.81 mmol/L) - Hepatic function: AST and ALT 1.5 X ULN unless liver metastases are present, then AST and ALT 5.0 X ULN; LDH 1.5 X ULN; bilirubin 1.5 mg/dL (0.026 mmol/L) Corrected calculated calcium 10 mg/dL (2.5 mmol/L) Calculation = total calcium - 0.707 (albumin -3.4)Albumin 3.0 g/dL (0.45 mmol/L) 7. The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy. 8. The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures. Exclusion Criteria: A subject will be ineligible for study participation if any of the following criteria are met: 1. The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases. 2. The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits. 3. The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding. 4. The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures. 5. The subject has history of other previous malignancies within 5 years, with the exception of: - Adequately treated in situ carcinoma of the cervix uteri - Basal or squamous cell carcinoma of the skin
Total Enrollment:
Location and Contact Information:
The Center for Hematology-Oncology *Recruiting*
Boca Raton, Florida, 33486
United States
Recruiting Dolores Preiser 561-416-8869
Kansas City Cancer Centers Southwest *Recruiting*
Overland Park, Kansas, 66210
United States
Recruiting Vickie Thomas 913-234-0400
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting The New Patient Information line 800-392-1611
Albany Regional Cancer Center *Recruiting*
Albany, New York, 12208
United States
Recruiting Michele Butler 518-489-2607
Clinical Trials and Research Associates *Recruiting*
Montibello, California, 90640
United States
Recruiting Maribell Sunga 323-724-8769
UCLA School of Medicine *Recruiting*
Los Angeles, California, 90024
United States
Recruiting Nancy Moldawer 310-206-5930
University of Chicago Medical Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Beth Manchin 773-702-4135
Albany Regional Cancer Center *Recruiting*
Albany, New York, 12208
United States
Recruiting Michelle Butler 518-489-2607
Academic Hospital Groningen *Recruiting*
Groningen, ,
Netherlands
Recruiting Gerri Seiling 0031-50-3613213
Baylor College of Medicine *Recruiting*
Houston, Texas,
United States
Recruiting Christine Bivens 713-798-4628
US Oncology, P.A. *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Julie Morehouse 214-370-1238
Raleigh Hematology Oncology Clinic *Recruiting*
Cary, North Carolina, 27511
United States
Recruiting Diane Bracco 919-852-1994
Central indiana Cancer Center *Recruiting*
Indianapolis, Indiana, 46227
United States
Recruiting Cindy Elkins 317-859-5500
University of Michigan *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting Cindy Rekowski 734-647-9437
Texas Cancer Center *Recruiting*
Ft. Worth, Texas, 66210
United States
Recruiting Catherine Worsfold 817-338-4333
Academic Hospital Groningen *Recruiting*
Groningen, ,
Netherlands
Recruiting Gerri Seiling 0031-50-3613213
Texas Cancer Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Catherine Worsfold 817-338-4333
Arizona Cancer Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting General Triage Line 480-657-1350
Kansas City Cancer Centers Southwest *Recruiting*
Overland Park, Kansas, 66210
United States
Recruiting Vickie Thomas 913-234-0400
Virginia G. Piper Cancer Center *Recruiting*
Scottsdale, Arizona, 85258
United States
Recruiting General Triage Line 480-657-1350
Kansas City Oncology and Hematology Group *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Vickie Thomas 816-531-2740
Additional Information:
Study ID Numbers: M02-428;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073125
Other Carcinoma, Renal Cell Studies:
1. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
2. A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer
3. Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
4. Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma
5. Safety/Efficacy of a Vaccine Prepared from Dendritic Cells combined with Tumor Cells to Treat Advanced Kidney Cancer
Related Studies:
Other Carcinoma, Renal Cell Clinical Trials
Other Texas Clinical Trials
Other Ft. Worth Clinical Trials
Safety and Efficacy of ABT-510 in Subjects with Advanced Renal Cell Carcinoma
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