A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Thyroid Carcinoma
I. Determine the 1-year treatment failure rate in patients with inoperable locoregionally
advanced or metastatic medullary or differentiated thyroid carcinoma treated with
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).
I. Determine the toxicity of this drug in these patients. Determine the 1-year
progression-free rate in patients treated with this drug.
II. Determine the response rate and duration of response in patients treated with this drug.
III. Determine the time to treatment failure and time to subsequent therapy in patients
treated with this drug.
IV. Determine the time to disease progression and overall survival of patients treated with
V. Correlate the incidence rate of RAS, RAF, and RET mutations with clinical outcome in
patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to type of thyroid
carcinoma (medullary vs differentiated).
Patients receive tanespimycin intravenously (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.
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 3 years from study entry.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment failure status
Measured using Response Evaluation Criteria in Solid Tumors (RESIST) criteria. All patients meeting the eligibility criteria who have signed a consent form and begun treatment will be considered evaluable. Those who die will be considered to have failed treatment unless documented evidence clearly indicates no progression has occurred or that the death was in no way related to treatment.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|