Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004229
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-01-28
Brief Title:
Endostatin in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy
Status:
COMPLETED
Status Verified Date:
2002-12
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 endostatin in treating patients who have advanced solid tumors Endostatin may stop the growth of cancer by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the optimal biologic dose of endostatin in patients with advanced solid tumors
II Determine the safety and tolerability of this regimen in these patients III Determine the extent frequency and duration of tumor response in these patients on this regimen
IV Determine the pharmacokinetic profile and interpatient pharmacologic variability of this regimen in these patients
V Determine the recommended phase II dose and schedule of this regimen
OUTLINE This is a dose escalation study
Patients undergo a biopsy during prestudy and after the second course of treatment Patients receive endostatin IV daily for 4 weeks Patients on dose level 1-6 receive endostatin over 20 minutes Patients on dose level 7 receive endostatin over 40 minutes with no treatment on day 2 of the first course only Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of endostatin 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
Patients are followed for 1 month
I Determine the optimal biologic dose of endostatin in patients with advanced solid tumors
II Determine the safety and tolerability of this regimen in these patients III Determine the extent frequency and duration of tumor response in these patients on this regimen
IV Determine the pharmacokinetic profile and interpatient pharmacologic variability of this regimen in these patients
V Determine the recommended phase II dose and schedule of this regimen
OUTLINE This is a dose escalation study
Patients undergo a biopsy during prestudy and after the second course of treatment Patients receive endostatin IV daily for 4 weeks Patients on dose level 1-6 receive endostatin over 20 minutes Patients on dose level 7 receive endostatin over 40 minutes with no treatment on day 2 of the first course only Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of endostatin 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
Patients are followed for 1 month
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 |
|---|---|---|---|
| CDR0000067471 | REGISTRY | PDQ Physician Data Query | None |
| MDA-ID-99201 | None | None | None |
| NCI-T99-0087 | None | None | None |