Status:
COMPLETED
FR901228 in Treating Patients With Recurrent High-Grade Gliomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of FR901228 (depsipeptide) in patients with recurrent malignant gliomas who are taking enzyme-inducing antiepileptic drugs (EIAEDs). ...
Eligibility Criteria
Inclusion
- 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 drugs
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00085540
Start Date
January 1 2005
End Date
March 1 2009
Last Update
January 2 2017
Active Locations (8)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
University of California San Francisco
San Francisco, California, United States, 94143
3
National Cancer Institute Neuro-Oncology Branch
Bethesda, Maryland, United States, 20814
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115