Thalidomide in Treating Patients With Thyroid Cancer
This study has been completed.
Sponsor:
University of Kentucky
Collaborator:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00026533
First received: November 9, 2001
Last updated: July 7, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas |
Resource links provided by NLM:
Further study details as provided by University of Kentucky:
| Study Start Date: | June 2001 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026533
Locations
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0298 | |
Sponsors and Collaborators
University of Kentucky
Investigators
| Study Chair: | Kenneth Ain, MD | Lucille P. Markey Cancer Center at University of Kentucky |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kenneth Ain, MD, University Kentucky |
| ClinicalTrials.gov Identifier: | NCT00026533 History of Changes |
| Other Study ID Numbers: | CDR0000069053, UKMC-IRB-010069 |
| Study First Received: | November 9, 2001 |
| Last Updated: | July 7, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Kentucky:
|
stage IV papillary thyroid cancer stage IV follicular thyroid cancer thyroid gland medullary carcinoma recurrent thyroid cancer insular thyroid cancer |
Additional relevant MeSH terms:
|
Carcinoma Thyroid Neoplasms Head and Neck Neoplasms Thyroid Diseases Adenocarcinoma, Follicular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Endocrine System Diseases Adenocarcinoma Thalidomide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013