NCT00098813

Brief 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. It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

December 19, 2013

Completed
Last Updated

May 28, 2014

Status Verified

October 1, 2013

Enrollment Period

4.8 years

First QC Date

December 8, 2004

Results QC Date

October 29, 2013

Last Update Submit

May 13, 2014

Conditions

Recurrent Thyroid CancerStage IV Follicular Thyroid CancerStage IV Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

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

    From start of treatment to 8 weeks

Study Arms (1)

Treatment (romidepsin)

EXPERIMENTAL

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.

Drug: romidepsinOther: laboratory biomarker analysisProcedure: positron emission tomography

Interventions

romidepsinDRUG

Given IV

Also known as: FK228, FR901228, Istodax
Treatment (romidepsin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (romidepsin)
positron emission tomographyPROCEDURE

Correlative studies

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Treatment (romidepsin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +55 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center at Suffolk

Commack, New York, 11725, United States

Location

MeSH Terms

Conditions

Thyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, Papillary

Interventions

romidepsinMagnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. David Pfister
Organization
Memorial Sloan-Kettering Cancer Center
pfisterd@mskcc.org
646-888-4237

Study Officials

  • David Pfister

    Memorial Sloan-Kettering Cancer Center at Suffolk

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2004

First Posted

December 9, 2004

Study Start

October 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 28, 2014

Results First Posted

December 19, 2013

Record last verified: 2013-10

Locations

US(1)