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Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003850
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date April 1999
View Details
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