Recurrent Thyroid Cancer Clinical Trial
Official title:
A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Thyroid Carcinoma
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | April 2012 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) | The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. |
1 year | No |
Secondary | Overall Response | The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0. Complete Response (CR): Disappearance of all lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD. |
Baseline, every 3 courses, and at the end of treatment study | No |
Secondary | Progression-Free Survival | Defined as the time from registration to the date of progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method. | Every 3 months for up to 3 years | No |
Secondary | Overall Survival | Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method. | Every 3 months until progression, and then every 6 months up to 3 years | No |
Secondary | Toxicity | Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles) | No |
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