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Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer

NCT ID: NCT00946673

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.

Detailed Description

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Conditions

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Brain Cancer Neoplasm Metastasis Lung Cancer Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vorinostat & stereotactic radiosurgery

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

Orally up to 400 mg

Radiation Therapy

Intervention Type PROCEDURE

Single fraction stereotactic radiotherapy - Standard of Care

Interventions

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Vorinostat

Orally up to 400 mg

Intervention Type DRUG

Radiation Therapy

Single fraction stereotactic radiotherapy - Standard of Care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
* Adequate organ function (section 3.1.10).
* ECOG performance status 0-2.
* Life expectancy of \>=12 weeks.
* Systemic chemotherapy washout period \>=7 days.

Exclusion Criteria

Patients who have previously been treated with whole brain irradiation, pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Griffith R Harsh

Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Griffith R. Harsh

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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LUN0036

Identifier Type: -

Identifier Source: org_study_id