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Thalidomide in Treating Patients With Thyroid Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026533
First Posted: January 27, 2003
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth Ain, University of Kentucky
  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 Kenneth Ain, 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)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026533


Locations
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0298
Sponsors and Collaborators
Kenneth Ain
National Cancer Institute (NCI)
Investigators
Study Chair: Kenneth Ain, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Responsible Party: Kenneth Ain, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT00026533     History of Changes
Other Study ID Numbers: CDR0000069053
UKMC-IRB-010069
First Submitted: November 9, 2001
First Posted: January 27, 2003
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by Kenneth Ain, 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:
Head and Neck Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents


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