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Recurrent Thyroid CancerPhase 2NCT00118248

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

A Phase 2 study testing tanespimycin in people with Recurrent Thyroid Cancer and Stage IV Follicular Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tanespimycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
Dec 2004to Apr 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
tanespimycin
Medical subject headings
Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary, Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tanespimycinDrug

    Also called 17-AAG

    Given IV

Study groups in NCT00118248
Study groupRoleWhat they receive
Treatment (chemotherapy)ExperimentalPatients 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.
Receives: Drug: tanespimycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, every 3 courses, and at the end of treatment study

  2. 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.

    Measured: Every 3 months for up to 3 years

  3. 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.

    Measured: Every 3 months until progression, and then every 6 months up to 3 years

  4. 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.

    Measured: Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionAug 2009
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118248
Sponsor's protocol ID
NCI-2009-00063
Other IDs
NCI-2009-00063, JHOC-B/06/174, NCI-6482, JHOC-JS0652, CDR0000433150, MC0476, 6482, N01CM62205
Status last verified
Dec 2016
First submitted
8 Jul 2005
Last updated
15 Feb 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tanespimycin in people with Recurrent Thyroid Cancer and Stage IV Follicular Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 60 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00118248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.

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