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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038181 |
The goal of this clinical research study is to find out whether it is safe to treat patients diagnosed with locally advanced prostate cancer with the drug Thalidomide before removing the tumor (radical retropubic prostatectomy).
Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate cancer before the surgery
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Thalidomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed by Radical Retropubic Prostatectomy (RRP) in Select Patients With Locally Advanced Prostate Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | October 2000 |
Estimated Study Completion Date: | December 2004 |
To obtain qualitative measurements of thalidomide's effect in vivo on:
endothelial cells / neo-vascularity /angiogenic growth factors:
epithelial compartment:
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
The only approved consent form is appended to this protocol.
Exclusion criteria
Study ID Numbers: | ID00-089 |
Study First Received: | May 29, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00038181 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer |
Anti-Bacterial Agents Immunologic Factors Thalidomide Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Angiogenesis Inhibitors Immunosuppressive Agents Prostatic Neoplasms |
Anti-Infective Agents Genital Neoplasms, Male Prostatic Diseases Thalidomide Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Prostatic Neoplasms Leprostatic Agents |