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Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth Ain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky

Authority:

United States: Federal Government

Study ID:

CDR0000069053

NCT ID:

NCT00026533

Start Date:

June 2001

Completion Date:

December 2005

Related Keywords:

  • Head and Neck Cancer
  • stage IV papillary thyroid cancer
  • stage IV follicular thyroid cancer
  • thyroid gland medullary carcinoma
  • recurrent thyroid cancer
  • insular thyroid cancer
  • Carcinoma
  • Thyroid Neoplasms
  • Head and Neck Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular

Name

Location

Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084