NCT00365053 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-06-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Toxicity Profile

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outcome · POSTED

Apoptosis by TUNEL Assay

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outcome · POSTED

Histone Acetylation by IHC and Western Blotting

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: belinostat
Other: laboratory biomarker analysis
label
Treatment (belinostat)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (belinostat)
description
Given IV
name
belinostat
other Names
PXD101
type
DRUG
arm Group Labels
Treatment (belinostat)
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 13
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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
measure
Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
time Frame
Up to 3 years

secondary Outcomes

description
Estimated using the product-limit method of Kaplan and Meier.
measure
Overall Survival
time Frame
Up to 3 years
description
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
measure
Progression-free Survival
time Frame
Up to 3 years
description
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
measure
Toxicity Profile
time Frame
Up to 3 years
description
Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
measure
Apoptosis by TUNEL Assay
time Frame
At baseline
description
Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
measure
Histone Acetylation by IHC and Western Blotting
time Frame
At baseline and at 4 hours after last dose of PXD101 on day 5

Full study description

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.
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 survival and time to progression in these patients. II. Assess the toxicities associated with this drug in these patients. III. Perform molecular correlative studies on tumor tissue (optional) and peripheral blood (required) and identify potential predictive markers for response. OUTLINE: 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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-03c5395b510d9d255bd9
requested nct id
NCT00365053
primary nct id
NCT00365053
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Malignant+Mesothelioma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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id
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link basis
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nct id
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occurrences
context exact
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end
11
exact text
NCT00365053
start
0
offset unit
unicode_code_points
query cond
Malignant Mesothelioma
query disease state id
ds-malignant-mesothelioma
source file
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source file sha256
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source json pointer
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source kind
ctgov_condition_query
source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Malignant+Mesothelioma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice