Thalidomide in Treating Patients With Thyroid Cancer

NCT ID: NCT00026533

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2005-12-31

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.

Conditions

Head and Neck Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Kenneth Ain

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Ain

Sponsor/PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth Ain, MD

Role: STUDY_CHAIR

Lucille P. Markey Cancer Center at University of Kentucky

Locations

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

UKMC-IRB-010069

Identifier Type: -

Identifier Source: secondary_id

CDR0000069053

Identifier Type: -

Identifier Source: org_study_id