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Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Clinical research trials and Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer. Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer  Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a double-blind randomized phase III study designed to determine if thalidomide can improve the efficacy of the LHRH agonist (leuprolide) in hormone-responsive patients with a rising PSA after primary definitive therapy for prostate cancer. Patients with only a rising PSA will be randomized to leuprolide for six months followed by oral thalidomide 200 mg per day or placebo. At the time of PSA progression, leuprolide will be restated for six additional months. After six months, patients originally treated with thalidomide will be crossed over to placebo and patients originally treated with placebo will be crossed over to thalidomide and followed until PSA progression or the development of metastatic disease, whichever occurs first. Additional information will be obtained on the changes in the circulating levels of the following growth factors: bFGF, TNF, VEGF, and TGFbeta. Likewise we will monitor changes in testosterone and DHT throughout the study. Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration.
Details: This is a double-blind randomized phase III study designed to determine if thalidomide can improve the efficacy of the LHRH agonist (leuprolide or goserelin) in hormone-responsive patients with a rising PSA after primary definitive therapy for prostate cancer. Patients with only a rising PSA will be randomized to LHRH agonist for six months followed by oral thalidomide 200 mg per day or placebo (Phase A). At the time of PSA progression, an LHRH agonist will be restarted for six additional months. After six months, patients originally treated with thalidomide will be crossed over to placebo and patients originally treated with placebo will be crossed over to thalidomide and followed until PSA progression or the development of metastatic disease, whichever occurs first (Phase B). Additional information will be obtained on changes in the circulating levels of the following growth factors: bFGF, TNF, VEGF, and TGFbeta. Likewise we will monitor changes in testosterone and DHT throughout the study. Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA Patients must have PSA only androgen dependent adenocarcinoma of the prostate. All patients must have failed definitive therapy (radical prostatectomy, radiation therapy with external beam or brachytherapy, or cryosurgery). Patients must have a negative CT scan and Bone Scan for metastatic prostate cancer. Patients must have histopathological documentation of prostate cancer. Every attempt should be made to have slides and blocks reviewed at NCI Pathology laboratory. The review of pathology by the NCI will not delay enrollment. Patients must have progressive prostate cancer. Two consecutively rising PSAs above the nadir post-definitive therapy and an absolute value greater than 1.0 ng/ml separated by at least 2 weeks. Patients must have a life expectancy of more than 12 months. Patients must have a performance status of 0 to 2 according to the ECOG criteria. Hematological eligibility parameters (within 2 weeks of starting therapy): Granulocyte count greater than or equal to 1,000/mm(3). Platelet count greater than or equal to 75,000/mm(3). Biochemical eligibility parameters (within 2 weeks of starting therapy): If the creatinine is greater than 2.0 mg/dL obtain a 24 hour urine collection. Creatinine clearance must be greater than 40 mL/min. Hepatic function: bilirubin (total) less than or equal to 1mg/dL upper limit of normal; ALT less than 2.5 times upper limit of normal. Exception: Patients with Clinical Gilbert's Syndrome may have total bilirubin less than or equal to 2.5 mg/dL. Patients must not have other concurrent malignancies (within the past 2 years, with the exception of nonmelanoma skin cancer and Rai Stage 0 chronic lymphoma leukemia), in situ carcinoma of any site, or life threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning thalidomide). Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), New York class II-IV congestive heart failure, chronic obstructive lung disease requiring oxygen therapy, uncontrolled seizure activity or by medical judgement of the physician, are not eligible. Patients must be able to understand and sign an informed consent document. Patients must be willing to travel from their home to the NIH or the participating institution (LSU, Univ. of Washington, Columbia University, Wayne State, University of Minnesota, University of Pittsburg, Holy Cross) for follow-up visits (due to sedation associated with thalidomideit is preferred that patients not drive during the first 3 days of taking daily dosing, or if sedation appears to be a continuing complication). Patients must be greater than or equal to18 years of age. Male patients must be counseled about the possibility that thalidomide may be present in semen. Men must use a latex condom every time they have sexual intercourse with women during therapy and for 8 weeks after discontinuing thalidomide, even if they have had a successful vasectomy. Patients may enroll as a late entry if the following criteria are met: Have received luprolide or goserelin within 3 months of starting study, have a PSA within two weeks of hormonal injection and have a bone scan and CT scan without metastasis within 8 weeks of enrollment. Patients with Rai Stage 0 Chronic Lymphocytic Leukemia (lymphocytosis only) will be eligible. EXCLUSION CRITERIA Patients that have received leuprolide, DES, flutamide, bicalutamide, PC-SPES, goserelin, cytotoxic chemotherapy, finasteride and/or nilutamide within the past year (or currently) are not eligible. Patients that received these agents for adjuvant or neoadjuvant therapy at the time of definitive therapy are eligible. Exception: Patients enrolled under late entry criteria, who have received luprolide/goserelin within 3 months of starting study are eligible. Patients with NCI/CTEP grade 2 or greater peripheral neuropathy of any cause that is clinically detectable, patients receiving anti-convulsive medications, and patients with a history of seizures within the past 10 years will not be eligible for this study. Patients who are receiving sedative/hypnotic agents (i.e. benzodiazepines) which cannot be discontinued, will not be eligible for this study. Patients who have had a surgical orchiectomy will not be eligible for this study. Patients who received systemic chemotherapy therapy for prostate cancer will not be eligible. Patients with a confirmed psychiatric history of a major depression consistent with American Psychiatric Association Diagnostic and Statistical Manual (DSM IIIR criteria), confirmed by a psychiatrist, will not be eligible.
Total Enrollment: 280
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Jane Carter 3014355614
Additional Information:
Study ID Numbers: 000080; 00-C-0080
Study Start Date: February 16, 2000
Record last reviewed: October 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004635
Other Prostate Cancer Studies:
1. A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
2. Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer
3. Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer
4. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
5. GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
Related Studies:
Other Prostate Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
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