Clinical trial · Interventional
FR901228 in Treating Patients With Recurrent High-Grade Gliomas
A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas
NCT00085540CI-TRIAL-00025311completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Brain Tumor | Adult Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| depsipeptide | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Escalation - Romidepsin
- description
- Patients 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
- interventionNames
- Drug: depsipeptide
- type
- EXPERIMENTAL
- label
- Phase 2 Dose from Phase 1 - Romidepsin
- description
- Patients 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
- interventionNames
- Drug: depsipeptide
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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%
* More than 8 weeks
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL (transfusions allowed)
* SGOT \< 2 times upper limit of normal (ULN)
* Bilirubin \< 2 times ULN
* Creatinine \< 1.5 mg/dL
* No congestive heart failure (i.e., New York Heart Association class II-IV, ejection fraction \< 40% by MUGA scan or \< 50% by echocardiogram and/or MRI)
* No myocardial infarction within the past year
* No uncontrolled dysrhythmias
* No poorly controlled angina
* No significant left ventricular hypertrophy by EKG
* No cardiac ischemia (ST depression of 2 mm) by EKG
* No hypertrophic or restrictive cardiomyopathy from prior treatment or other causes
* No uncontrolled hypertension (i.e., blood pressure ≥ 160/95 mm Hg)
* No cardiac arrhythmia requiring antiarrhythmic medication
* No known cardiac abnormalities (e.g., congenital long QT syndrome and QTc interval \> 480 milliseconds)
* No history of sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, or cardiac arrest unless controlled with concurrent automatic implantable cardioverter defibrillator
* No known history of coronary artery disease (e.g., Canadian class II-IV angina)
* No other significant cardiac disease
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No active infection
* No significant uncontrolled medical illness that would preclude study participation
* No disease that would obscure toxicity or dangerously alter drug metabolism
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 2 weeks after study participation
* Fertile male patients must continue barrier contraception for 3 months after study participation
* At least 1 week since prior interferon or thalidomide
* No concurrent prophylactic filgrastim (G-CSF)
* No concurrent anticancer immunotherapy
* At least 2 weeks since prior vincristine
* At least 6 weeks since prior nitrosoureas
* At least 3 weeks since prior procarbazine
* No prior FR901228 (depsipeptide)
* No other concurrent anticancer chemotherapy
* See Disease Characteristics
* At least 1 week since prior tamoxifen
* No concurrent anticancer hormonal therapy
* See Disease Characteristics
* No concurrent anticancer radiotherapy
* See Disease Characteristics
* Prior recent resection of recurrent or progressive tumor allowed if patient has recovered
* Recovered from all prior therapy
* At least 2 weeks since prior EIAEDs (patients in Group A only)
* At least 4 weeks since prior cytotoxic therapy
* At least 4 weeks since prior investigational agents
* At least 1 week since prior isotretinoin
* At least 1 week since other prior non-cytotoxic therapy (except radiosensitizers)
* No concurrent valproic acid
* No concurrent hydrochlorothiazide
* No concurrent medication that causes QTc prolongation
* No other concurrent anticancer therapy
* No other concurrent investigational drugsReferences
Publications (1)
- DERIVEDIwamoto 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 21377994