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Phase II Study of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Inoperable Locoregionally Advanced or Metastatic Medullary or Differentiated Thyroid Carcinoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
17-AAG in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II | Treatment | Active | 18 and over | MAYO-MC0476 6482, NCI-6482, NCT00118248, JHOC-JS0652, JHOC-B/06/174 |
Special Category:
NCI Web site featured trial Objectives Primary - 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).
Secondary - Determine the toxicity of this drug in these patients.
- Determine the 1-year progression-free rate in patients treated with this drug.
- Determine the response rate and duration of response in patients treated with this drug.
- Determine the time to treatment failure and time to subsequent therapy in patients treated with this drug.
- Determine the time to disease progression and overall survival of patients treated with this drug.
- Correlate the incidence rate of RAS, RAF, and RET mutations with clinical outcome in patients treated with this drug.
Entry Criteria Disease Characteristics:
- 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
Prior/Concurrent Therapy:
Biologic therapy - 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])
Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
Endocrine therapy Radiotherapy - 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
Surgery - More than 4 weeks since prior therapeutic surgery for the tumor
Other - 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL
Hepatic - Bilirubin ≤ normal
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- AST ≤ 1.5 times ULN
Renal - Creatinine ≤ 1.5 times ULN
Cardiovascular - 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
Immunologic - No uncontrolled infection
- No history of serious allergic reaction to eggs
Pulmonary - 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)
Other - 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
Expected Enrollment 72A total of 28-72 patients (14-36 per stratum) will be accrued for this study within 24 months. Outcomes Primary Outcome(s)Treatment failure at 1 year
Secondary Outcome(s)Toxicity Overall survival Time to disease progression Overall response rate (complete and partial) Correlation of the incidence rate of RAS, RAF, and RET mutations with clinical response Time to treatment failure
Outline This is a multicenter study. Patients are stratified according to type of thyroid carcinoma (medullary vs differentiated). Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 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.
Trial Contact Information
Trial Lead Organizations Mayo Clinic Cancer Center | | | Jeffrey Moley, MD, Protocol chair | | | | Robert Smallridge, MD, Protocol co-chair | | | | Trial Sites
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U.S.A. |
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District of Columbia |
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Washington |
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| | | | Howard University Cancer Center |
| | Clinical Trials Office - Howard University Cancer Center | |
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Florida |
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Jacksonville |
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| | | Mayo Clinic - Jacksonville |
| | Clinical Trials Office - All Mayo Clinic Locations | |
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Maryland |
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Baltimore |
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| | | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| | Manuel Hidalgo, MD, PhD | |
| Email:
mhidalg1@jhmi.edu |
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Michigan |
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Detroit |
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| | | Barbara Ann Karmanos Cancer Institute |
| | Patricia LoRusso, DO | |
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Minnesota |
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Rochester |
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| | | Mayo Clinic Cancer Center |
| | Clinical Trials Office - All Mayo Clinic Locations | |
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Missouri |
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Saint Louis |
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| | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | Jeffrey Moley, MD | |
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Ohio |
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Columbus |
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| | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | Ohio State University Cancer Clinical Trial Matching Service | |
| Email:
osu@emergingmed.com |
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Wisconsin |
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Madison |
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| | | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center |
| | Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
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China |
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Hong Kong |
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| | | Prince of Wales Hospital |
| | Brigette Ma, MD | |
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Republic of Singapore |
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Singapore |
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| | | Cancer Institute at National University Hospital |
| | Boon Goh, MD | |
| | Johns Hopkins Singapore International Medical Centre |
| | Alex Chang, MD | |
| Email:
alexchang@imc.jhmi.edu |
| | National Cancer Centre - Singapore |
| | Darren Wan Teck, MD | |
| Email:
dmolwt@nccs.com.sg |
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Related Information Featured trial article
Registry Information | | Official Title | | A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Carcinoma of the Thyroid | | Trial Start Date | | 2004-12-08 | | Trial Completion Date | | 2006-06-01 (estimated) | | Registered in ClinicalTrials.gov | | NCT00118248 | | Date Submitted to PDQ | | 2005-05-03 | | Information Last Verified | | 2009-01-13 | | NCI Grant/Contract Number | | CA15083, CM17104 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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