Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305747
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2006-03-21
Brief Title:
Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study of Bioresponse-dim in Non-Metastatic Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA
Status:
COMPLETED
Status Verified Date:
2014-01
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:
RATIONALE Diindolylmethane may slow the growth of prostate cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy
PURPOSE This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy
Detailed Description:
OBJECTIVES
Primary
Establish the maximum tolerated dose dose-limiting toxicity and a recommended phase II dose of absorption-enhanced diindolylmethane BioResponse-DIM BR-DIM in patients with nonmetastatic hormone-refractory prostate cancer and rising serum prostate-specific antigen PSA levels
Evaluate the toxicities of BR-DIM
Secondary
Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population
Evaluate the effect of BR-DIM supplementation on serum PSA level
Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation
Determine quality of life measures in patients taking BR-DIM supplementation
OUTLINE This is an open-label dose-escalation study
Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane BioResponse-DIM BR-DIM twice daily on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
Quality of life is assessed at baseline on day 1 of each course and at the completion of study therapy
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Establish the maximum tolerated dose dose-limiting toxicity and a recommended phase II dose of absorption-enhanced diindolylmethane BioResponse-DIM BR-DIM in patients with nonmetastatic hormone-refractory prostate cancer and rising serum prostate-specific antigen PSA levels
Evaluate the toxicities of BR-DIM
Secondary
Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population
Evaluate the effect of BR-DIM supplementation on serum PSA level
Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation
Determine quality of life measures in patients taking BR-DIM supplementation
OUTLINE This is an open-label dose-escalation study
Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane BioResponse-DIM BR-DIM twice daily on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
Quality of life is assessed at baseline on day 1 of each course and at the completion of study therapy
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-2979 | None | None | None |
| WSU-0507002581 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |