Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Completed · Phase 1/Phase 2
Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
In brief
This phase I/II trial is studying the side effects and best dose of belinostat and to see how well it works in treating patients with liver cancer that cannot be removed by surgery. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Key facts
- Study ID
- NCT00321594
- Run by
- National Cancer Institute (NCI)
- People needed
- 54
- Starts
- 2006-05-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2017-11-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed hepatocellular carcinoma that is not amenable to curative resection
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with MRI or spiral CT scan
- No known brain metastases
- No clinical ascites or encephalopathy
- Life expectancy > 12 weeks
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.7 mg/dL
- Albumin ≥ 2.8 mg/dL
- ALT ≤ 5.0 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 6 times ULN
- Prothrombin time ≤ 4 sec above ULN
- Creatinine ≤ 1.6 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients use effective contraception
- No Child's-Pugh's grading Class C hepatic impairment
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PXD101
- No marked baseline prolongation of QT/QTc interval, including the following:
- Repeated demonstration of a QTc interval > 500 msec
- Long QT Syndrome
- No ongoing or active infection
- No significant cardiovascular disease, including any of the following:
Where it is running
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
- Cancer Therapeutics Research Group — Singapore, Singapore
Full record on ClinicalTrials.gov
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