Case Evaluation

Mesothelioma Clinical Trials: PXD101 Clinical Trial

 

Sponsors and Collaborators:
California Cancer Consortium
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00365053

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition
Intervention
Phase
Malignant Mesothelioma
 Drug: belinostat
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological markers
 Procedure: biological therapy
 Procedure: diagnostic test
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
 Procedure: reverse transcriptase-polymerase chain reaction

Study Type: Interventiona

Study Design: Treatment, Open Label

Official Title: Phase II Study of PXD 101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

  • Primary Outcome Measures:
    • Objective tumor response rate as measured by RECIST criteria
  • Secondary Outcome Measures:
    • Overall survival by Kaplan-Meier
    • Time to progression by Kaplan-Meier
    • Toxicity profile
    • Effect of PXD101 on apoptosis and histone acetylation as measured by TUNEL assay, immunohistochemistry, and western blot
    • Total Enrollment: 37 Study start: June 2006

OBJECTIVES:

  • Primary:
    • Determine the objective response rate in patients with unresectable malignant pleural Mesothelioma (MPM) treated with PXD101.
  • Secondary:
    • Determine the overall survival and time to progression in these patients.
    • Assess the toxicities associated with this drug in these patients.
    • Perform molecular correlative studies on tumor tissue (optional) and peripheral blood (required) and identify potential predictive markers for response.

OUTLINE: This is a multicenter study.

  • Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Patients undergo blood collection during course 1 of treatment for biomarker correlative studies. Fetal hemoglobin (hemoglobin F) levels are measured via reverse transcriptase-polymerase chain reaction as a potential predictive marker for response.
  • After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL:

  • A total of 37 patients will be accrued for this study.
  • Eligibility
    • Ages Eligible for Study: 18 Years and above,
    • Genders Eligible for Study: Both

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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

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