NCT00086827

Brief Summary

This phase II trial is studying how well FR901228 works in treating patients with recurrent small cell lung cancer. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 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

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

April 10, 2014

Status Verified

December 1, 2012

Enrollment Period

2.5 years

First QC Date

July 8, 2004

Last Update Submit

April 9, 2014

Conditions

Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    95% confidence intervals will be estimated.

    Up to 4 years

Secondary Outcomes (3)

  • Overall survival

    Between registration and death, assessed up to 4 years

  • Failure-free survival

    The time between registration and disease progression or death, assessed up to 4 years

  • The frequency of toxicity occurrence, graded using the NCI CTCAE version 3.0

    Up to 4 years

Study Arms (1)

Treatment (romidepsin)

EXPERIMENTAL

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have continuing tumor response or stable disease after 6 courses receive 2 additional courses beyond best response.

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:

  • Either histologic or cytologic documentation of recurrent small cell lung carcinoma (SCLC)
  • No more than 1 prior chemotherapy regimen; must have recurrent disease after treatment with a platinum agent (either cisplatin or carboplatin); prior chemotherapy must have been completed ≥90 days prior to documentation of relapse
  • \>= 4 weeks since prior radiation therapy; prior radiation therapy is allowed either in the context of curative intent combined modality treatment for limited stage disease, prophylactic cranial radiation or palliative radiation (to the chest, brain, or other sites) initially or at relapse
  • Prior surgery is allowed provided patients have completely recovered from effects of procedure and \>= 2 weeks have elapsed
  • No prior treatment with depsipeptide
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to depsipeptide
  • No current treatment with any other investigational agent or drugs known to have HDI activity (HDAC or histone deacetylase inhibitor) such as sodium valproate
  • Patients with treated/controlled brain mets (defined as no need for further radiation and no requirements for steroids to control peri-tumoral edema) are eligible for this study; however, patients requiring treatment with enzyme inducing anti-convulsant drugs are not eligible; these include, but are not limited to, phenytoin, phenobarbital, carbamazepine, felbamate and primidone
  • All Patients must have Measurable Disease
  • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension; the longest diameter of measurable lesions must be \>= 20 mm with conventional techniques or \>= 10 mm with spiral CT scan; lesions that are not considered measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • +16 more criteria

You may not qualify if:

  • Non-pregnant and non-nursing because of significant risk to the fetus/infant; the effects of depsipeptide on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because histone deacetylase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and for the entire duration of participation and for at least 6 weeks after completion of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gregory Otterson

    Cancer and Leukemia Group B

    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

July 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

November 1, 2006

Last Updated

April 10, 2014

Record last verified: 2012-12

Locations

US(1)