Study on Lenvatinib for Locally Advanced Invasive Thyroid Cancer

Sponsor: Massachusetts Eye and Ear Infirmary

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04321954

Provider View

This clinical trial is testing the safety and effectiveness of the drug lenvatinib when given before surgery to patients with invasive thyroid cancer that has spread beyond the thyroid gland.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug lenvatinib works when given before surgery to remove tumors in patients with invasive thyroid cancer that has spread beyond the thyroid gland. The study will involve 30 participants and will include screening for eligibility, treatment with lenvatinib, and follow-up visits. Lenvatinib is not yet approved by the FDA for this specific type of thyroid cancer, but it is approved for other uses. This Phase II trial aims to test the safety and effectiveness of lenvatinib for this condition.

Description

This study is being conducted at multiple centers and is open to patients with invasive thyroid cancer that has spread beyond the thyroid gland. Participants will receive lenvatinib before undergoing surgery to remove the cancerous tumors. The study will include screening for eligibility, treatment with lenvatinib, and follow-up visits to monitor the effects of the treatment.

Lenvatinib is a study drug that has been approved for other uses but is being tested here for its effectiveness in treating this specific type of thyroid cancer. The study aims to determine if lenvatinib can improve surgical outcomes for patients with this condition. Participants will be closely monitored for safety and effectiveness of the treatment.

The study is expected to enroll 30 participants. It is important to note that lenvatinib is considered investigational for this specific use, meaning it is still being studied to determine its effectiveness and safety for treating invasive thyroid cancer that has spread beyond the thyroid gland.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide written consent.
  • Diagnosed with locally advanced thyroid cancer or recurrent thyroid cancer that has spread beyond the thyroid gland.
  • Types of thyroid cancer include papillary, follicular, Hürthle cell, and poorly differentiated thyroid carcinoma.
  • Evidence of cancer spreading beyond the thyroid, such as vocal cord paralysis or involvement of nearby structures like the trachea or esophagus.
  • Measurable disease by standard criteria.
  • Good overall health with a performance status of 0 or 1.
  • Controlled blood pressure and adequate organ function.
  • Ability to swallow pills.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during the study and for 30 days after.
  • Women of childbearing potential must have a negative pregnancy test before starting the study drug.

Exclusion Criteria

  • Diagnosis of medullary or anaplastic thyroid carcinoma.
  • Tumors blocking the airway or completely encasing major blood vessels.
  • Recent significant bleeding or blood clots.
  • Recent treatment with blood thinners, except low-dose aspirin.
  • Previous radiation therapy to the neck.
  • Previous treatment with lenvatinib or similar drugs.
  • Cancer spread to the brain.
  • Pregnant or breastfeeding women.
  • Significant protein in urine or conditions affecting drug absorption.
  • Active infection requiring treatment.
  • Serious heart conditions or recent heart attack or stroke.
  • Abnormal heart rhythm or prolonged QT interval on ECG.
  • Allergic reactions to similar drugs.
  • Any condition that would prevent participation in the study.

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