NCT00026533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2001

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2.4 years

First QC Date

November 9, 2001

Last Update Submit

June 4, 2017

Conditions

Head and Neck Cancer

Keywords

stage IV papillary thyroid cancerstage IV follicular thyroid cancerthyroid gland medullary carcinomarecurrent thyroid cancerinsular thyroid cancer

Interventions

thalidomideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0298, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid Cancer, PapillaryAdenocarcinoma, FollicularCarcinoma, MedullaryThyroid Neoplasms

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsAdenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kenneth Ain, MD

    Lucille P. Markey Cancer Center at University of Kentucky

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor/PI

Study Record Dates

First Submitted

November 9, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

November 1, 2003

Study Completion

December 1, 2005

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

US(1)