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Recurrent Thyroid CancerPhase 2NCT00098813

Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine

A Phase 2 study testing romidepsin, laboratory biomarker analysis and positron emission tomography 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 romidepsin works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
romidepsin, laboratory biomarker analysis and positron emission tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2004to Aug 2009
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

  • Histologically or cytologically confirmed non-medullary thyroid carcinoma, including the following cell types:
  • Papillary
  • Follicular
  • Variants of papillary or follicular
  • Hürthle cell
  • Recurrent and/or metastatic disease
Show all 70Show fewer
  • Measurable disease
  • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • Progressive disease during or after prior treatment, as defined by >= 1 of the following criteria:
  • Presence of new or progressive lesions on CT scan or MRI
  • New lesions on bone or positron-emission tomography scan
  • Rising thyroglobulin level
  • Minimum of 3 consecutive rises with an interval of >= 1 week between each determination
  • Refractory to radioactive iodine (RAI)
  • Absent or insufficient RAI-uptake documented by whole-body RAI scan within the past 6 months
  • At least 1 lesion with absent RAI-uptake required for insufficient uptake
  • No known brain metastases
  • Performance status - Karnofsky 60-100%
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,00/mm^3
  • Bilirubin normal
  • AST and ALT =< 2.5 times upper limit of normal
  • Chronic active viral hepatitis allowed provided patient is clinically stable and fulfills liver function eligibility criteria
  • Creatinine normal
  • Creatinine clearance >= 60 mL/min
  • QTc =< 480 msec by ECG
  • ST segment depression < 2 mm
  • LVEF >= 50 % by echocardiogram
  • No left ventricular hypertrophy, as defined by end-diastolic wall thickness > 12 mm in both the left ventricular posterior wall as well as septum or restrictive cardiomyopathy
  • No history of any of the following cardiac diseases:
  • Canadian Cardiovascular Society (CCS) class II-IV angina pectoris
  • Myocardial infarction within the past 12 months
  • Sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator
  • Any cardiac arrhythmia requiring digitalis or another antiarrhythmic medication other than a beta blocker or calcium channel blocker
  • No uncontrolled hypertension (i.e., blood pressure >= 160/95)
  • Mobitz II second degree block in patients who do not have a pacemaker
  • First degree or Mobitz I second degree block, bradyarrhythmias or sick sinus syndrome require Holter monitoring and evaluation by cardiology
  • Uncontrolled dysrhythmias
  • No history of congenital long QT syndrome
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Thyroid stimulating hormone normal or suppressed
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No other concurrent uncontrolled illness
  • At least 4 weeks since prior biologic or targeted agents (e.g., interferon alfa, thalidomide, octreotide, or cetuximab)
  • No concurrent antineoplastic biologic agents
  • No prior FR901228 (depsipeptide)
  • No prior cytotoxic chemotherapy
  • Cytotoxic chemotherapy as a radiosensitizer allowed provided >= 3 months since prior administration
  • No other concurrent antineoplastic chemotherapy
  • Not specified
  • At least 4 weeks since prior external beam radiation therapy
  • Documented disease progression required if patient received external beam radiotherapy to index lesions
  • At least 3 months since prior RAI therapy
  • Diagnostic studies using =< 12 mCi of RAI are not considered RAI therapy
  • No concurrent antineoplastic radiotherapy
  • At least 2 weeks since prior anticancer cyclooxygenase-2 (COX-2) inhibitors, isotretinoin, or complementary medications
  • At least 4 weeks since prior tyrosine kinase inhibitors (e.g., gefitinib or erlotinib)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent drugs known to have histone deacetylase inhibitor activity (e.g., valproic acid)
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent hydrochlorothiazide
  • No concurrent treatment dose warfarin
  • No concurrent agents that cause QTc prolongation
  • Concurrent daily aspirin given after myocardial infarction or COX-2 inhibitors at standard anti-inflammatory or pain doses allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center at Suffolk

    Commack, New York, 11725

Other trials in United States

About this study

Official title: A Phase II Study of Single Agent Depsipeptide (FK228) in Radioiodine (RAI)-Refractory Metastatic Non-medullary (Papillary, Follicular, and Hurthle Cell Variants) Thyroid Carcinoma

This phase II trial is studying how well romidepsin works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the antitumor activity of romidepsin (depsipeptide), in terms of the proportion of patients achieving a complete or partial response or disease stabilization, in patients with progressive recurrent and/or metastatic non-medullary thyroid carcinoma that is refractory to radioactive iodine (RAI).

II. Determine the safety and tolerability of this drug in these patients.

SECONDARY OBJECTIVES:

  1. Document changes in RAI uptake by comparing pre- and post-treatment RAI scans in patients treated with this drug.

II. Evaluate changes in the expression of the Na+/I- symporter (NIS) in tumors, as measured by immunohistochemistry on pre- and post-treatment biopsy specimens; and real time reverse transcriptase polymerase chain reaction (RT-PCR) for NIS mRNA on pre- and post-treatment changes biopsy specimens.

III. Determine post-treatment changes in serum thyroglobulin in patients treated with this drug.

IV. Correlate changes in post-treatment positron-emission tomography scans with whole-body RAI scans in patients treated with this drug.

OUTLINE:

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

Being tested
romidepsin, laboratory biomarker analysis, positron emission tomography
Medical subject headings
Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary

What participants receive

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

  • romidepsinDrug

    Also called FK228, FR901228, Istodax

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Correlative studies

Study groups in NCT00098813
Study groupRoleWhat they receive
Treatment (romidepsin)ExperimentalPatients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
Receives: Drug: romidepsin; Other: laboratory biomarker analysis; Procedure: positron emission tomography

What is being measured

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

  1. Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria

    Measured: From start of treatment to 8 weeks

Timeline

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

  1. First posted9 Dec 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionAug 2009
  4. Study completionAug 2009

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098813
Sponsor's protocol ID
NCI-2012-01458
Other IDs
04-059, N01CM62206, CDR0000396783
Status last verified
Oct 2013
First submitted
8 Dec 2004
Last updated
28 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing romidepsin, laboratory biomarker analysis and positron emission tomography 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 70 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 28 May 2014. 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 19 Dec 2013). 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?

Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria (time frame: From start of treatment to 8 weeks). 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 NCT00098813.

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 28 May 2014.

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