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Thalidomide in Treating Patients With Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
Sponsored by
Kenneth Ain
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, recurrent thyroid cancer, insular thyroid cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert B. Chandler Medical Center, University of Kentucky

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2001
Last Updated
June 4, 2017
Sponsor
Kenneth Ain
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00026533
Brief Title
Thalidomide in Treating Patients With Thyroid Cancer
Official Title
Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Ain
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, recurrent thyroid cancer, insular thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ain, MD
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Study Chair
Facility Information:
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0298
Country
United States

12. IPD Sharing Statement

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Thalidomide in Treating Patients With Thyroid Cancer

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