Status:
COMPLETED
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Advanced Malignant Mesothelioma
Epithelial Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 may stop the growth...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101. SECONDARY OBJECTIVES: I. Determine the overall s...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes:
- Epithelial
- Sarcomatoid
- Mixed
- Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma
- Prior intrapleural cytotoxic agents (including bleomycin) not considered systemic chemotherapy
- Patients who are not candidates for combination chemotherapy are eligible even if they have not received prior chemotherapy
- Unresectable disease
- Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
- The sole site of measurable disease must not be located within the radiotherapy port
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 3 months
- WBC \>= 3,000/mm\^3
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Bilirubin normal
- AST/ALT =\< 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance \>= 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception for 1 week before, during, and for \>= 2 weeks after completion of study treatment
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
- No symptomatic congestive heart failure
- No congestive heart failure related to primary cardiac disease
- No unstable angina pectoris
- No cardiac arrhythmia
- No condition requiring anti-arrhythmic therapy
- No uncontrolled hypertension
- No myocardial infarction within the past 6 months
- No ischemic or severe valvular heart disease
- No ongoing or active infection
- No marked baseline prolongation of QT/QTc interval
- No repeated QTc interval \> 500 msec
- No long QT syndrome
- No other significant cardiovascular disease
- No other uncontrolled intercurrent illness
- No psychiatric illness or social situation that would preclude study compliance
- Recovered from prior therapy
- No prior valproic acid or other known histone deacetylase (HDAC) inhibitor
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- More than 3 weeks since prior radiation therapy
- No concurrent medication that may cause torsade de pointes
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00365053
Start Date
June 1 2006
End Date
March 1 2009
Last Update
June 7 2018
Active Locations (1)
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1
City of Hope
Duarte, California, United States, 91010