Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00026533
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00026533
Study Brief:
Protocol Section:
NCT00026533