PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery

Study 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 of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedbelinostat and laboratory biomarker analysis

The study team can explain what participation involves.

Who it may be forMesothelioma · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 7, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Interventions being studied: Drug: belinostat; Other: laboratory biomarker analysis

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Disease setting

Recurrent or relapsed→

Treatment approach

Surgery→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of HopeDuarte, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 7, 2018. Always confirm current availability with the study team.

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