Thalidomide in Treating Patients With Thyroid Cancer
Thalidomide in Treating Patients With Thyroid Cancer
RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the
 tumor.

 PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have
 thyroid cancer.
OBJECTIVES:

 -  Determine the antitumor activity of thalidomide, in terms of tumor response and duration
 of response, in patients with metastatic follicular, papillary, or medullary thyroid
 carcinoma that is unresponsive to systemic radioiodine.

 -  Compare the differences in antitumor activity of this drug in patients with medullary
 carcinomas vs those with papillary or follicular carcinomas.

 -  Determine the toxic effects and duration of toxic effects of this drug in these
 patients.

 OUTLINE: Patients receive oral thalidomide once daily for 2 weeks and then twice daily.
 Treatment continues for 1 year in the absence of disease progression or unacceptable
 toxicity.

 PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed follicular, papillary, insular, or medullary thyroid
 carcinoma

 -  Must meet criteria for 1 of the following:

 -  Unresectable, distantly metastatic tumor that does not concentrate radioactive
 iodine

 -  Follicular or papillary thyroid carcinoma with a large distant tumor burden that
 has not sufficiently responded to cumulative iodine I 131 doses exceeding 800 mCi

 -  Radiographic evidence of tumor progression, meeting 1 of the following criteria:

 -  Evidence gathered over a period of at least 1 year with at least 3 separate x-ray
 studies, defining tumor volume

 -  Similar radiographic evidence over a shorter period of time, delineating more
 than 30% increase in tumor volume

 PATIENT CHARACTERISTICS:

 Age:

 -  18 and over

 Performance status:

 -  Karnofsky 70-100%

 Life expectancy:

 -  Not specified

 Hematopoietic:

 -  Absolute neutrophil count at least 750/mm^3

 -  Hemoglobin at least 10.5 g/dL

 Hepatic:

 -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

 Renal:

 -  Creatinine no greater than 1.5 times ULN

 -  BUN no greater than 1.5 times ULN

 Other:

 -  No active infection not controlled with medications

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective double contraception (1 hormonal method plus 1
 barrier method OR 2 simultaneous barrier methods) for female patients or barrier
 contraception for male patients for more than 4 weeks prior to, during, and for at
 least 4 weeks after study participation

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  No prior thalidomide

 -  No other concurrent biologic therapy

 Chemotherapy:

 -  At least 4 weeks since prior systemic chemotherapy

 -  No concurrent systemic chemotherapy

 Endocrine therapy:

 -  Not specified

 Radiotherapy:

 -  See Disease Characteristics

 -  Prior radiotherapy allowed

 -  Concurrent limited external-beam radiotherapy to isolated sites of bony metastases
 allowed, provided that these sites are not the sole sites of metastatic disease and do
 not constitute the sites of evaluable disease for this study

 -  No concurrent radioiodine therapy

 Surgery:

 -  See Disease Characteristics

 -  Prior surgery allowed

 -  Concurrent surgery allowed to sites that do not constitute evaluable disease for this
 study

 Other:

 -  No concurrent medications that are known to increase the risk of peripheral neuropathy