NCT00365053

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

December 29, 2014

Completed
Last Updated

June 7, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

August 16, 2006

Results QC Date

July 9, 2014

Last Update Submit

May 4, 2018

Conditions

Advanced Malignant MesotheliomaEpithelial MesotheliomaRecurrent Malignant MesotheliomaSarcomatous Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Up to 3 years

Secondary Outcomes (5)

  • Overall Survival

    Up to 3 years

  • Progression-free Survival

    Up to 3 years

  • Toxicity Profile

    Up to 3 years

  • Apoptosis by TUNEL Assay

    At baseline

  • Histone Acetylation by IHC and Western Blotting

    At baseline and at 4 hours after last dose of PXD101 on day 5

Study Arms (1)

Treatment (belinostat)

EXPERIMENTAL

Patients receive PXD101 IV at 1000 mg/m2 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.

Drug: belinostatOther: laboratory biomarker analysis

Interventions

belinostatDRUG

Given IV

Also known as: PXD101
Treatment (belinostat)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (belinostat)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Mesothelioma, MalignantSolitary Fibrous Tumor, Pleural

Interventions

belinostat

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesSolitary Fibrous TumorsNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Results Point of Contact

Title
DCC Project Administrator
Organization
California Cancer Consortium
CCCP@coh.org
626-256-4673

Study Officials

  • Suresh Ramalingam

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 7, 2018

Results First Posted

December 29, 2014

Record last verified: 2018-05

Locations

US(1)