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CompletedNCT00086827Updated Apr 10, 2014

Romidepsin in Treating Patients With Relapsed Small Cell Lung Cancer

A Phase 2 interventional study of romidepsin and laboratory biomarker analysis in Recurrent Small Cell Lung Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-10.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the response rate of patients with histologically or cytologically proven small cell lung cancer (SCLC) treated with depsipeptide in the "sensitive" relapse setting.

SECONDARY OBJECTIVES:

I. To describe the overall survival and failure-free survival of patients with histologically proven recurrent SCLC treated with depsipeptide.

II. To evaluate the toxicity of depsipeptide in patients with relapsed SCLC. III. To evaluate surrogate biological markers from peripheral blood mononuclear cells and buccal epithelial cells: p53 acetylation, histone acetylation, p21CIP1 expression.

OUTLINE:

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.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

02

Conditions studied

  • Recurrent Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area
  • ECOG Performance Status 0-1
  • No significant cardiac disease, including:
  • Congestive heart failure that meets New York Heart Association (NYHA) class III/IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or poorly controlled angina
  • History of serious ventricular arrhythmia (VT or VF, >= 3 beats in a row), QTc >= 500 msec, or LVEF =\< 40% by MUGA
  • Evidence of left ventricular hypertrophy by echocardiographic criteria or by EKG criteria (Cornell voltage criteria):

For Men: S in V3 plus R in aVL > 2.8 mV (28mm) For Women: S in V3 + R in aVL > 2.0 mV (20mm)

  • Patients may not be co-medicated with an agent that causes QTc prolongation
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are not eligible because of possible pharmacokinetic interactions with depsipeptide
  • No current treatment with potassium wasting diuretics (e.g., hydroclorothiazide); patients on such diuretics should be switched to a potassium sparing diuretic or another antihypertensive medication prior to registration
  • Granulocytes >= 1,500/μl
  • Platelets >= 100,000/μl
  • Total Bilirubin =\< 1.5 x ULN
  • AST (SGOT) =\< 2.5 x ULN
  • Creatinine ≤1.5 x ULN OR Calculated Creatinine Clearance >= 60 ml/min

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Treatment (romidepsin)

    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: romidepsin · Other: laboratory biomarker analysis

Interventions

  • Drugromidepsin

    Given IV

    Also known as: FK228, FR901228, Istodax

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Objective response rate

    95% confidence intervals will be estimated.

    Time frame: Up to 4 years

Secondary outcomes

  1. Overall survival

    Described using Kaplan-Meier curves.

    Time frame: Between registration and death, assessed up to 4 years

  2. Failure-free survival

    Described using Kaplan-Meier curves.

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

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

    Tabulated by type and grade.

    Time frame: Up to 4 years

07

Study locations

1 site
  • Ohio State University
    Columbus, Ohio 43210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00086827
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 12, 2004
Start date
May 2004
Primary completion
Nov 2006
Last update
Apr 10, 2014

Study contacts

Gregory Otterson
principal investigator · Cancer and Leukemia Group B
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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