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Thalidomide in Treating Patients With Thyroid Cancer
This study is ongoing, but not recruiting participants.
Study NCT00026533   Information provided by National Cancer Institute (NCI)
First Received: November 9, 2001   Last Updated: July 23, 2008   History of Changes

November 9, 2001
July 23, 2008
June 2001
 
 
 
Complete list of historical versions of study NCT00026533 on ClinicalTrials.gov Archive Site
 
 
 
Thalidomide in Treating Patients With Thyroid Cancer
Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas

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.

Phase II
Interventional
Treatment
Head and Neck Cancer
Drug: thalidomide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026533
 
CDR0000069053, UKMC-IRB-010069
Lucille P. Markey Cancer Center at University of Kentucky
National Cancer Institute (NCI)
Study Chair: Kenneth Ain, MD Lucille P. Markey Cancer Center at University of Kentucky
National Cancer Institute (NCI)
August 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP