Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:

• Progressive or recurrent disease

• Metastatic disease

• Unresectable disease

• Meeting any of the following thyroid cancer subtypes:

• Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory

• Undifferentiated thyroid cancer (i.e., anaplastic disease)

• Medullary thyroid cancer

• Must have received prior everolimus or other mTOR inhibitor therapy

• Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed

PATIENT CHARACTERISTICS:

• Karnofsky performance score 70-100%

• ANC ≥ 1,500/mm^³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 5.6 mmol/L

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)

• Serum creatinine ≤ 2 times ULN

• Negative pregnancy test

• No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics