Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 7:21 AM
Study NCT ID:
NCT00030095
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.
PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.
Detailed Description:
OBJECTIVES:
* Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.
* Determine the side effect profile of this drug in these patients.
* Determine the pharmacokinetic profile of this drug in these patients.
* Determine the changes in positron-emission tomography scans of patients treated with this drug.
* Determine the changes in apotosis in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at day 30.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
* Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.
* Determine the side effect profile of this drug in these patients.
* Determine the pharmacokinetic profile of this drug in these patients.
* Determine the changes in positron-emission tomography scans of patients treated with this drug.
* Determine the changes in apotosis in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at day 30.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
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?: