NCT00084461

Brief Summary

Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

June 10, 2004

Last Update Submit

June 3, 2013

Conditions

GastrinomaGlucagonomaInsulinomaMetastatic Gastrointestinal Carcinoid TumorPancreatic Polypeptide TumorPulmonary Carcinoid TumorRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRegional Gastrointestinal Carcinoid TumorSomatostatinoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Frequency of response will be estimated with a 95% confidence interval.

    Up to 4 weeks

Secondary Outcomes (1)

  • Incidence of toxicity

    Up to 4 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 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses beyond CR.

Drug: romidepsinOther: laboratory biomarker analysis

Interventions

romidepsinDRUG

Given IV

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

Correlative studies

Treatment (romidepsin)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed carcinoid tumor or islet cell neuroendocrine tumor
  • Well- or moderately-differentiated tumor
  • Metastatic and/or locally advanced disease
  • Measurable disease
  • Unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Lesions in a previously irradiated area are not considered measurable
  • No truly non-measurable lesions, including the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural or pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging
  • Cystic lesions
  • Ineligible for standard treatment
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

GastrinomaGlucagonomaInsulinomaCarcinoma, Islet CellSomatostatinoma

Interventions

romidepsin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenoma, Islet CellAdenomaCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and Embryonal

Study Officials

  • Manisha Shah

    Ohio State University

    PRINCIPAL INVESTIGATOR

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

June 10, 2004

First Posted

June 11, 2004

Study Start

March 1, 2004

Primary Completion

October 1, 2004

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)