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Home > "T" Clinical Trials Conditions > Thalidomide in Treating Patients With Thyroid Cancer  Thalidomide in Treating Patients With Thyroid Cancer
Thalidomide in Treating Patients With Thyroid Cancer
For Condition: insular thyroid cancer,medullary thyroid cancer,stage 4 follicular thyroid cancer,recurrent thyroid cancer,stage 4 papillary thyroid cancer
Status: No longer recruiting
Sponsor(s): University of Kentucky , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KennethAin, Study Chair, University of Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0298
United States
Additional Information:
Study ID Numbers: CDR0000069053; UKMC-IRB-010069
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026533
Other Medullary Thyroid Cancer Studies:
1. Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
2. Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer
3. Thalidomide in Treating Patients With Thyroid Cancer
Related Studies:
Other medullary thyroid cancer Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
Thalidomide in Treating Patients With Thyroid Cancer
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