FR901228 in Treating Patients With Recurrent High-Grade Gliomas
A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas
4 other identifiers
interventional
50
1 country
8
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2005
Longer than P75 for phase_1
8 active sites
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
First Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedStudy Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
November 15, 2016
CompletedJanuary 2, 2017
November 1, 2016
3.9 years
June 10, 2004
September 23, 2016
November 15, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose-limiting Toxicities Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I)
dose limiting toxicity defined as: ANC \</=1000 or Platelets \<100K; SGOT \>/= 3X ULN and T. Bili \>/= 1.5 ULN grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI)
First 4 weeks of treatment
6 Months Progression-free Survival (Phase II)
evaluated patients with glioblastoma (GBM (35 patients)
At 6 months
Secondary Outcomes (1)
Response Rate Associated With Depsipeptide Therapy (Phase II)
Up to 2 years
Study Arms (2)
Phase 1 Dose Escalation - Romidepsin
EXPERIMENTALPatients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation two dose levels: Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2 Pharmacokinetics
Phase 2 Dose from Phase 1 - Romidepsin
EXPERIMENTALPatients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Romidepsin (depsipeptide): 13.3mg/m2
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Phase I and phase II:
- Histologically confirmed recurrent intracranial malignant glioma, including any of the following:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant astrocytoma not otherwise specified
- Unequivocal evidence of tumor progression by MRI or CT scan while on a steroid dosage that has been stable for at least 5 days
- Patients previously treated with interstitial brachytherapy or stereotactic radiosurgerymust have confirmation of true progressive disease (rather than radiation necrosis) by positron-emission tomography, thallium scan, magnetic resonance spectroscopy, or surgical documentation
- Must have failed prior radiotherapy that was completed at least 6 weeks ago
- No more than 2 prior therapies (initial treatment and treatment for 1 relapse)\*
- Surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks, followed by a second surgical resection, is considered treatment for 1 relapse
- Patients in group B must have been receiving enzyme-inducing antiepileptic drugs (EIAEDs) for at least the past 2 weeks
- Performance status - Karnofsky 60-100%
- +55 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California San Francisco
San Francisco, California, 94143, United States
National Cancer Institute Neuro-Oncology Branch
Bethesda, Maryland, 20814, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
Iwamoto FM, Lamborn KR, Kuhn JG, Wen PY, Yung WK, Gilbert MR, Chang SM, Lieberman FS, Prados MD, Fine HA. A phase I/II trial of the histone deacetylase inhibitor romidepsin for adults with recurrent malignant glioma: North American Brain Tumor Consortium Study 03-03. Neuro Oncol. 2011 May;13(5):509-16. doi: 10.1093/neuonc/nor017. Epub 2011 Mar 3.
PMID: 21377994DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Dose escalation was terminated after 2 dose levels because PK parameters of romidepsin in pts receiving EIAEDs were similar to those reported in Adults not receiving CYP34A inducing drugs, we wanted to avoid the expected dose limiting toxicity.
Results Point of Contact
- Title
- Howard Fine, MD
- Organization
- Adult Brain Tumor Consortium (ABTC)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Fine, MD
North American Brain Tumor Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- 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
January 1, 2005
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
January 2, 2017
Results First Posted
November 15, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share