Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001446
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2000-08
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 is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer
An important aspect of this study is to characterize the pharmacokinetics of thalidomide as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide
An important aspect of this study is to characterize the pharmacokinetics of thalidomide as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide
Detailed Description:
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer Patients will be randomized to two different treatment arms low dose versus high dose An important aspect of this study is to characterize the pharmacokinetics of thalidomide as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide Each patient that has biopsiable lesions will undergo a pretreatment biopsy of their prostate or other site of soft tissue disease and repeat after 2 to 6 months of treatment Additional information will be obtained on the changes in the circulating levels of the following growth factors bFGF TNF VEGF and TGFB Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-C-0178 | None | None | None |