RATIONALE: Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer.

Condition	Treatment or Intervention	Phase
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent metastatic squamous neck cancer with occult primary stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the hypopharynx	Drug: thalidomide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven squamous cell carcinoma of the head and neck; Recurrent disease OR Metastatic disease at initial diagnosis or at recurrence
• Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed
• No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease
• Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics
• Chemotherapy: See Disease Characteristics; Any number of courses of one regimen of chemotherapy allowed; No concurrent cytotoxic chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; No concurrent radiotherapy
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-2
• Life expectancy: At least 3 months
• Hematopoietic: WBC at least 3000/mm3; Platelet count at least 100,000/mm3; Hematocrit at least 30%
• Hepatic: Bilirubin no greater than 1.5 times normal; SGOT/SGPT no greater than 1.5 times normal
• Renal: Creatinine no greater than 1.5 mg/dL
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study; Men must use effective barrier contraception during and for 1 month after study; No grade 2 or greater peripheral neuropathy; No serious infection or other concurrent illness requiring immediate therapy; Must be able to take oral medications; No medical or social factors that would interfere with compliance

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Roy Herbst,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067011; MDA-ID-98270; NCI-T98-0074
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003850
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08