Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT00003850
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2001-01
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 II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor.
Detailed Description:
OBJECTIVES:
I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
II. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.
OUTLINE:
Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.
I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
II. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.
OUTLINE:
Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.
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?: