Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer

NCT ID: NCT00118248

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2012-04-30

Brief 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.

Detailed Description

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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 this drug.

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.

Conditions

Recurrent Thyroid Cancer; Stage IV Follicular Thyroid Cancer; Stage IV Papillary Thyroid Cancer; Thyroid Gland Medullary Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

tanespimycin

Intervention Type: DRUG

Given IV

Interventions

tanespimycin

Given IV

Intervention Type: DRUG

Other Intervention Names

17-AAG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Moley

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2009-00063

Identifier Type: REGISTRY

Identifier Source: secondary_id

JHOC-B/06/174

Identifier Type: -

Identifier Source: secondary_id

NCI-6482

Identifier Type: -

Identifier Source: secondary_id

JHOC-JS0652

Identifier Type: -

Identifier Source: secondary_id

CDR0000433150

Identifier Type: -

Identifier Source: secondary_id

MC0476

Identifier Type: OTHER

Identifier Source: secondary_id

6482

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00063

Identifier Type: -

Identifier Source: org_study_id

NCT01646944

Identifier Type: -

Identifier Source: nct_alias

NCT01664351

Identifier Type: -

Identifier Source: nct_alias