Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00026533
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2001-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Patients With Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}, {'id': 'D018263', 'term': 'Adenocarcinoma, Follicular'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-04', 'studyFirstSubmitDate': '2001-11-09', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IV papillary thyroid cancer', 'stage IV follicular thyroid cancer', 'thyroid gland medullary carcinoma', 'recurrent thyroid cancer', 'insular thyroid cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor.\n\nPURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Compare the differences in antitumor activity of this drug in patients with medullary carcinomas vs those with papillary or follicular carcinomas.\n* Determine the toxic effects and duration of toxic effects of this drug in these patients.\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed follicular, papillary, insular, or medullary thyroid carcinoma\n* Must meet criteria for 1 of the following:\n\n * Unresectable, distantly metastatic tumor that does not concentrate radioactive iodine\n * 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\n* Radiographic evidence of tumor progression, meeting 1 of the following criteria:\n\n * Evidence gathered over a period of at least 1 year with at least 3 separate x-ray studies, defining tumor volume\n * Similar radiographic evidence over a shorter period of time, delineating more than 30% increase in tumor volume\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 750/mm\\^3\n* Hemoglobin at least 10.5 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n* BUN no greater than 1.5 times ULN\n\nOther:\n\n* No active infection not controlled with medications\n* Not pregnant or nursing\n* Negative pregnancy test\n* 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\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior thalidomide\n* No other concurrent biologic therapy\n\nChemotherapy:\n\n* At least 4 weeks since prior systemic chemotherapy\n* No concurrent systemic chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Prior radiotherapy allowed\n* 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\n* No concurrent radioiodine therapy\n\nSurgery:\n\n* See Disease Characteristics\n* Prior surgery allowed\n* Concurrent surgery allowed to sites that do not constitute evaluable disease for this study\n\nOther:\n\n* No concurrent medications that are known to increase the risk of peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT00026533', 'briefTitle': 'Thalidomide in Treating Patients With Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas', 'orgStudyIdInfo': {'id': 'CDR0000069053'}, 'secondaryIdInfos': [{'id': 'UKMC-IRB-010069'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'thalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536-0298', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Albert B. Chandler Medical Center, University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Kenneth Ain, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lucille P. Markey Cancer Center at University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kenneth Ain', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor/PI', 'investigatorFullName': 'Kenneth Ain', 'investigatorAffiliation': 'University of Kentucky'}}}}