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Medullary Thyroid CancerPhase 4NCT01915485

Radiolabeled Molecules for Medullary Thyroid Cancer

A Phase 4 study testing Lu 177 in people with Medullary Thyroid Cancer, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Medullary Thyroid Cancer
What is being tested?
Lu 177
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
Aug 2013to Feb 2017
Phase
Phase 4
Are there results?
None posted in the registry

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

  • Medullary Thyroid Cancer
  • Doubling time calcitonin and CEA less than 6 months
  • Measurable disease by cross- sectional imaging
  • Irresectable tumors masses
  • > 18 years of age

Who cannot join

  • < 18 years of age
  • Disease that can be treated with new surgical procedure
  • Stable disease

Trial locations and contacts

1 site in 1 country.

Fernanda Vaisman, MD, PhD contact

(5521) 32071387

fevaisman@globo.com

Brazil1 site, 1 recruiting
  • Instituto Nacional do Cancer do Rio de Janeiro

    Rio de Janeiro, Rio de Janeiro

    Fernanda Vaisman, fvaisman@inca.gov.br

    Fernanda Vaisman, MD

    Recruiting

Other trials in Brazil

About this study

Official title: The Use of Lu177 in the Treatment of Progressive and Unresectable Metastatic Medullary Thyroid Cancer

Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate which is a ligand to somatostatin receptors.

Read the detailed description

Medullary thyroid carcinomas can also be located by scintigraphy with 111In-DTPA (diethylenetriamine pentaacetic acid) -octreotide. In some studies, there is a sensitivity for the detection of these tumors by this method, 50-70%. The relationship of calcitonin and carcinoembryonic antigen levels were significantly higher in patients in whom scintigraphy was performed with 111In-DTPA-octreotide. This implies that somatostatin receptors can be detected "in vivo" for different forms of medullary thyroid carcinoma Based on the specific binding of the analogs of somatostatin receptors present on the membrane of some tumors such as medullary thyroid been possible to devise a therapy to target-directed using both beta-emitting radionuclides (which have therapeutic properties) coupled to such molecules. The main radiopharmaceuticals used for this purpose are currently 177 Lu-DOTA-Tyr3-OCTREOTATE or 90Yttrium-DOTA]-TOC.

The medullary thyroid carcinoma (MTC) is a rare neuroendocrine tumor, accounting for only 4.9% of total thyroid carcinomas, however, compared to well differentiated carcinoma, presents a worse prognosis. The tumor staging, and restaging is essential since surgery is the only curative method. Elevated plasma concentrations of calcitonin (CT) and / or high levels of carcinoembryonic antigen (CEA), biochemical markers of MTC, suggest the presence of residual malignant disease / recurrence or metastasis at a distance. After surgery aggressive 40% of patients have persistent disease and about 10%, with undetectable post-surgery CT, develop tumor recurrence. At this point the therapeutic options are scarce and not available in our area. Although the investigators use the structural radiological study using ultrasound, computed tomography and magnetic resonance imaging for staging of the disease, they do not provide functional information. In this context, nuclear medicine examinations can add data such as growth potential and expression pattern of receptors for diagnostic and therapeutic purposes. In 2007, Ong SC. et al. Showed that 18 FDG PET / CT have the ability to detect residual disease, recurrent or metastatic disease with a sensitivity of 78% but only when calcitonin is up 1000pg/ml. Already Iten et al. Using the principle that these tumors express receptors for the somatostatin used OctreoScan ® and subsequent treatment with 90Yttrium-DOTA]-TOC showing not only an advantage for the location of the disease and the possibility of making an image guided therapy by. These authors also demonstrated a clinical benefit to the extent that 25% of the patients showed reduced calcitonin. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate.

Being tested
Lu 177
Medical subject headings
Carcinoma, Medullary

What participants receive

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

  • Lu 177Radiation

    Patients will be submitted to 4 cycles of 177-Lu with 200mCi each

Study groups in NCT01915485
Study groupRoleWhat they receive
Lu 177Experimentalprogressive metastatic medullary thyroid cancer
Receives: Radiation: Lu 177

What is being measured

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

  1. Tumour Shrinkage

    RECIST 1.1 criteria

    Measured: 6-8 months

Secondary outcomes (1)
  1. Quality of life improvement

    SF 36 pre and post therapy

    Measured: 6-8 months

Timeline

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

  1. First posted5 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionNov 2016 (estimated)
  4. Study completionFeb 2017 (estimated)

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01915485
Sponsor's protocol ID
Lu177-med
Status last verified
Sep 2016
First submitted
1 Aug 2013
Last updated
7 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Iten F, Muller B, Schindler C, Rochlitz C, Oertli D, Macke HR, Muller-Brand J, Walter MA. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6696-702. doi: 10.1158/1078-0432.CCR-07-0935.

    PubMed 18006770

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lu 177 in people with Medullary Thyroid Cancer, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.

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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Fernanda Vaisman, MD, PhD ((5521) 32071387, fevaisman@globo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumour Shrinkage (time frame: 6-8 months). 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 NCT01915485, which also lists 1 linked publication.

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 7 Sep 2016.

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