Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
Recurrent Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer
About this trial
This is an interventional treatment trial for Recurrent Thyroid Cancer
Eligibility Criteria
Inclusion Criteria: Diagnosis of thyroid carcinoma of 1 of the following types: Medullary Differentiated Iodine I 131-resistant disease, defined as failure to incorporate and/or progression of measurable disease after treatment with iodine I 131 Inoperable locoregionally advanced or metastatic disease Measurable disease, defined as ≥ 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan No active CNS metastases Performance status - ECOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL Bilirubin ≤ normal Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) AST ≤ 1.5 times ULN Creatinine ≤ 1.5 times ULN QTc < 450 msec for male patients (470 msec for female patients) LVEF > 40% by MUGA DLCO ≥ 80% No cardiac symptoms ≥ grade 2 No active ischemic heart disease within the past year No congenital long QT syndrome No left bundle branch block No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) No myocardial infarction within the past year No New York Heart Association class III or IV congestive heart failure No poorly controlled angina No history of angina (of any sort) within the past 6 months No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs No history of cardiac toxicity after treatment with anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine) No other significant cardiac disease No uncontrolled infection No history of serious allergic reaction to eggs No pulmonary symptoms ≥ grade 2 No symptomatic pulmonary disease requiring medication including the following: Dyspnea on or off exertion Paroxysmal nocturnal dyspnea Oxygen requirement Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease) No home oxygen need meeting the Medicare criteria No history of pulmonary toxicity after treatment with anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma No active seizure disorder More than 4 weeks since prior and no concurrent immunotherapy More than 4 weeks since prior biologic therapy No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy See Disease Characteristics More than 4 weeks since prior and no concurrent radiotherapy More than 4 weeks since prior radiopharmaceuticals No prior radiotherapy to > 25% of bone marrow No prior radiotherapy that potentially included the heart in the field (i.e., mantle) or chest More than 4 weeks since prior therapeutic surgery for the tumor More than 3 months since prior sublingual nitroglycerin No other concurrent investigational ancillary therapy Concurrent CYP3A4 inhibitors allowed No concurrent medications that prolong or may prolong QTc interval
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy)
Patients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.