- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026533
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.
Study Overview
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Kentucky
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Lexington, Kentucky, United States, 40536-0298
- Albert B. Chandler Medical Center, University of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kenneth Ain, MD, Lucille P. Markey Cancer Center at University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Thyroid Diseases
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- CDR0000069053
- UKMC-IRB-010069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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