Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003850
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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:
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 |
|---|---|---|---|
| CDR0000067011 | REGISTRY | PDQ Physician Data Query | None |
| MDA-ID-98270 | None | None | None |
| NCI-T98-0074 | None | None | None |