Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003219
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
1999-11-01
Brief Title:
Perillyl Alcohol in Treating Patients With Metastatic Breast Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Phase II Trial of Perillyl Alcohol NSC 641066 Administered Daily in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic breast cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic breast cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the clinical effectiveness ie objective tumor response time to treatment failure and survival of perillyl alcohol in patients with previously treated metastatic breast cancer II Define the acute and chronic toxic effects of perillyl alcohol in this patient population
OUTLINE Patients are given oral perillyl alcohol 4 times per day Dose escalation of perillyl alcohol may occur in individual patients if no unacceptable toxicity is observed Treatment is continued as long as the patient benefits from treatment does not show progressive disease and does not experience irreversible or life threatening toxicity Patients are evaluated for response monthly while receiving treatment on this study Patients are followed at 2-4 weeks after the last treatment
PROJECTED ACCRUAL Approximately 40 patients will be accrued over 2 years
OUTLINE Patients are given oral perillyl alcohol 4 times per day Dose escalation of perillyl alcohol may occur in individual patients if no unacceptable toxicity is observed Treatment is continued as long as the patient benefits from treatment does not show progressive disease and does not experience irreversible or life threatening toxicity Patients are evaluated for response monthly while receiving treatment on this study Patients are followed at 2-4 weeks after the last treatment
PROJECTED ACCRUAL Approximately 40 patients will be accrued over 2 years
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 |
|---|---|---|---|
| NCI-T97-0068 | US NIH GrantContract | None | httpsreporternihgovquickSearchR21CA072500 |
| R21CA072500 | NIH | None | None |
| WCCC-CO-9611 | None | None | None |