Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
Verified date | June 2017 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2005 |
Est. primary completion date | November 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Kenneth Ain | National Cancer Institute (NCI) |
United States,
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