CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
depsipeptidedrug
Likely dose
Depsipeptide IV (specific dose not stated)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed recurrent intracranial malignant glioma including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma NOS
  • ✓Unequivocal evidence of tumor progression by MRI or CT scan on stable steroid dosage for at least 5 days
  • ✓For prior brachytherapy or radiosurgery: confirmation of true progressive disease by PET, thallium scan, MR spectroscopy, or surgical documentation
  • ✓Prior radiotherapy completed at least 6 weeks ago
Key exclusion· 11
  • ✕Congestive heart failure (NYHA class II-IV, EF <40% by MUGA or <50% by echocardiogram/MRI)
  • ✕Myocardial infarction within the past year
  • ✕Uncontrolled dysrhythmias or cardiac arrhythmia requiring antiarrhythmic medication
  • ✕Poorly controlled angina or known coronary artery disease (Canadian class II-IV)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00085540
NCT00085540Phase 2Completed
CompareCT.gov

A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas

National Cancer Institute (NCI)·interventional·Posted Jun 11, 2004·Updated Jan 2, 2017

In Brief

A Phase 2 clinical trial evaluating depsipeptide for Adult Anaplastic Astrocytoma and 4 related conditions. Completed, enrolled 50 participants across 8 sites.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 22.1 years ago

Interventions

depsipeptidedrug

Given IV