Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002862
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Perillyl Alcohol in Treating Patients With Refractory Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF PERILLYL ALCOHOL IN PATIENTS WITH REFRACTORY MALIGNANCIES NSC 641066
Status:
COMPLETED
Status Verified Date:
2000-09
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:
Phase I trial to study the effectiveness of perillyl alcohol in treating patients with refractory cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Estimate the maximum tolerated dose of perillyl alcohol given chronically three times per day in patients with refractory malignancies
II Describe the toxic effects and pharmacokinetics associated with this regimen
III Evaluate any antitumor activity of perillyl alcohol in these patients IV Assess the ability of perillyl alcohol to induce tumor differentiation and reduce telomerase activity in patients from whom serial biopsies can be obtained
OUTLINE This is a dose escalation study to determine the maximum tolerated dose of perillyl alcohol
Groups of 3-6 patients receive escalating doses of oral perillyl alcohol three times per day until the maximum tolerated dose or recommended phase II dose is determined Treatment at the assigned dose continues until disease progression or unacceptable toxicity intervenes Patients with stable disease after 8 weeks of treatment are removed from study
Patients are followed for duration of response and survival
I Estimate the maximum tolerated dose of perillyl alcohol given chronically three times per day in patients with refractory malignancies
II Describe the toxic effects and pharmacokinetics associated with this regimen
III Evaluate any antitumor activity of perillyl alcohol in these patients IV Assess the ability of perillyl alcohol to induce tumor differentiation and reduce telomerase activity in patients from whom serial biopsies can be obtained
OUTLINE This is a dose escalation study to determine the maximum tolerated dose of perillyl alcohol
Groups of 3-6 patients receive escalating doses of oral perillyl alcohol three times per day until the maximum tolerated dose or recommended phase II dose is determined Treatment at the assigned dose continues until disease progression or unacceptable toxicity intervenes Patients with stable disease after 8 weeks of treatment are removed from study
Patients are followed for duration of response and survival
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 |
|---|---|---|---|
| YALE-HIC-8895 | None | None | None |
| NCI-T96-0064D | None | None | None |