Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004635
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2000-02-19
Brief Title:
Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Double Blinded Randomized Crossover Phase III Study of Oral Thalidomide Versus Placebo in Patients With Stage D0 Androgen Dependent Prostate Cancer Following Limited Hormonal Ablation
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multi-center study will evaluate whether thalidomide can improve the effectiveness of the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone production which in most patients reduces the size of the tumor Thalidomide a drug used for many years to treat leprosy blocks the growth of blood vessels that may be important to disease progression
Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or recurred after having had surgery radiation therapy or cryosurgery but whose disease has not metastasized spread beyond the prostate may be eligible for this study Candidates are screened with a medical history and physical examination including blood tests bone and computed tomography CT scans or other imaging studies
Study participants are randomly assigned to one of two treatment groups One group receives leuprolide or goserelin followed by thalidomide the other receives leuprolide or goserelin followed by placebo a look-alike pill with no active ingredients Patients in both groups receive an injection of leuprolide or goserelin once a month for 6 months After that time they take four capsules of either thalidomide or placebo once a day and remain on the drug until their prostate-specific antigen PSA level returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter whichever is lowerPSA is a protein secreted by the prostate gland Monitoring changes in levels of this protein can help evaluate tumor progression At this point the entire procedure begins again starting with leuprolide or goserelin treatment but the experimental drug is switched patients originally treated with thalidomide are crossed over to placebo and patients originally treated with placebo are crossed over to thalidomide
Patients are monitored periodically with the following tests and procedures
Medical histories and physical examinations Blood and urine tests to monitor thalidomide and PSA levels the response to treatment and routine laboratory values eg cell counts and kidney and liver function
Computed tomography CT and bone scans and possibly other imaging tests to assess the tumor
Electromyography EMG and nerve conduction studies as needed For electromyography a thin needle is inserted into a few muscles and the patient is asked to relax or to contract the muscles
Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or recurred after having had surgery radiation therapy or cryosurgery but whose disease has not metastasized spread beyond the prostate may be eligible for this study Candidates are screened with a medical history and physical examination including blood tests bone and computed tomography CT scans or other imaging studies
Study participants are randomly assigned to one of two treatment groups One group receives leuprolide or goserelin followed by thalidomide the other receives leuprolide or goserelin followed by placebo a look-alike pill with no active ingredients Patients in both groups receive an injection of leuprolide or goserelin once a month for 6 months After that time they take four capsules of either thalidomide or placebo once a day and remain on the drug until their prostate-specific antigen PSA level returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter whichever is lowerPSA is a protein secreted by the prostate gland Monitoring changes in levels of this protein can help evaluate tumor progression At this point the entire procedure begins again starting with leuprolide or goserelin treatment but the experimental drug is switched patients originally treated with thalidomide are crossed over to placebo and patients originally treated with placebo are crossed over to thalidomide
Patients are monitored periodically with the following tests and procedures
Medical histories and physical examinations Blood and urine tests to monitor thalidomide and PSA levels the response to treatment and routine laboratory values eg cell counts and kidney and liver function
Computed tomography CT and bone scans and possibly other imaging tests to assess the tumor
Electromyography EMG and nerve conduction studies as needed For electromyography a thin needle is inserted into a few muscles and the patient is asked to relax or to contract the muscles
Detailed Description:
This is a double-blind randomized phase III study designed to determine if thalidomide can improve the efficacy of the luteinizing hormone releasing hormone 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 basic fibroblast growth factor bFGF tumor necrosis factor TNF vascular endothelial growth factor VEGF and transforming growth factor beta TGFbeta Likewise we will monitor changes in testosterone and dihydrotestosterone DHT throughout the study Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000080 | OTHER | Clinical Center NIH | None |
| 00-C-0080 | OTHER | None | None |