Clinical trial NCT00026533: Thalidomide in Treating Patients With Thyroid Cancer
Official title: Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: stage IV papillary thyroid cancer
stage IV follicular thyroid cancer
thyroid gland medullary carcinoma
recurrent thyroid cancer
insular thyroid cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: Kenneth Ain, MD
role: STUDY_CHAIR
References: