QUILT-3.006 for Recurrent Medullary Thyroid Cancer

• INCLUSION CRITERIA:

Participants must meet the following criteria for participation:

• Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer. It is not uncommon for a secondary, minor pathologic focus of another form of thyroid cancer to be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, eligibility is based on the discretion of the investigator.
• Patients must have evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone, CT scan or MRI. (Patients who are surgical candidates and potentially rendered disease free with surgical resection are not eligible.)
• Patients must have elevated calcitonin levels, greater than 8 pg/mL in females and 16 pg/mL in males
• Patients with minimal or no disease related-symptoms (Minimal symptoms will include those that do not affect activities of daily living or pain that does not require regularly scheduled narcotics.)
• No brain metastasis, history of seizures, encephalitis, or multiple sclerosis.
• Age greater than or equal to 18 years
• ECOG performance status of 0-1 at study entry (Karnofsky greater than or equal to 70)
• No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.
• Hematological eligibility parameters
• Granulocyte count greater than or equal to 1,500/mm^3
• Platelet count greater than or equal to 100,000/mm^3
• Hemoglobin greater than or equal to 9 g/dL
• Biochemical eligibility parameters (within 16 days of starting therapy)
• Baseline renal function:

--- Serum creatinine less than or equal to 1.5 x upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min.

• Hepatic function:
• Bilirubin less than or equal to 1.5 mg/dl, in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL
• AST and ALT 1 cm or thoracic lesions larger than 2 cm will be excluded.
• Concurrent chemotherapy.
• Chronic hepatitis infection, including B and C, because potential immune impairment caused by these disorders may diminish the effectiveness of this immunologic therapy.
• Participation in another interventional clinical trial at the time of enrollment.
• Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
• Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
• Patients with second malignancy within 3 years of enrollment; patients treated surgically with a curative intent, such as non-melanoma skin cancers, localized kidney cancer or carcinoma in situ of the bladder, are not excluded. Patients with MEN2 and a history of pheochromocytoma will also not be excluded. In addition patients with prostate cancer who do not require systemic therapy will not be excluded. (A secondary, minor pathologic focus of another form of thyroid cancer may be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, eligibility is based on the discretion of the investigator.