Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-28 @ 8:26 AM
Study NCT ID:
NCT00006361
Status:
COMPLETED
Last Update Posted:
2009-12-04
First Post:
2000-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
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:
RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced or recurrent cancer of the head and neck.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced or recurrent cancer of the head and neck.
Detailed Description:
OBJECTIVES:
* Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck.
* Determine the safety and toxicity of SU5416 in these patients.
OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.
* Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck.
* Determine the safety and toxicity of SU5416 in these patients.
OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.
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?: