Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022425
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-08-10
Brief Title:
Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
Status:
UNKNOWN
Status Verified Date:
2003-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Chemoprevention therapy is the use of certain drugs to try to prevent the recurrence of cancer The use of perillyl alcohol may be effective in preventing the recurrence of breast cancer
PURPOSE Phase I trial to study the effectiveness of perillyl alcohol in preventing the recurrence of breast cancer in women who have been treated with surgery with or without adjuvant therapy
PURPOSE Phase I trial to study the effectiveness of perillyl alcohol in preventing the recurrence of breast cancer in women who have been treated with surgery with or without adjuvant therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of perillyl alcohol in women at risk for recurrent breast cancer
Determine the toxicity of this drug in these patients
Determine the single-dose and multiple-dose pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral perillyl alcohol once daily on days 1-28 Treatment continues every 4 weeks for 3 courses
Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience grade 2 or greater toxicity
Patients are followed weekly
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Determine the maximum tolerated dose of perillyl alcohol in women at risk for recurrent breast cancer
Determine the toxicity of this drug in these patients
Determine the single-dose and multiple-dose pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral perillyl alcohol once daily on days 1-28 Treatment continues every 4 weeks for 3 courses
Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience grade 2 or greater toxicity
Patients are followed weekly
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P01-0189 | None | None | None |
| CCF-IRB-3574 | None | None | None |
| CCF-N01-CN-55131 | None | None | None |