Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
Condition: Recurrent Thyroid Cancer; Stage IV Follicular Thyroid Cancer; Stage IV Papillary Thyroid Cancer; Thyroid Gland Medullary Carcinoma
MeSH terms: Carcinoma; Thyroid Neoplasms; Thyroid Cancer, Papillary; Carcinoma, Medullary; Adenocarcinoma, Follicular; Thyroid Diseases
Intervention: tanespimycin
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well tanespimycin works in treating patients with
      inoperable locoregionally advanced or metastatic thyroid cancer. Drugs used in chemotherapy,
      such as tanespimycin, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing.
    

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