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

Phase 1

Completed

• Conditions: Brain Cancer; Neoplasm Metastasis; Lung Cancer; Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Vorinostat; Procedure: Radiation Therapy

• Registration Number: NCT00946673
• Lead Sponsor: Stanford University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Primary Completion: 2014-07
• Study Completion: 2015-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vorinostat & stereotactic radiosurgery	Radiation Therapy	-
vorinostat & stereotactic radiosurgery	Vorinostat	-

Primary Outcome Measures

Name	Time	Method
The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.	3 months following Stereotactic Radiosurgery
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.	30 days following Stereotactic Radiosurgery
During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.	30 days following Stereotactic Radiosurgery

Secondary Outcome Measures

Name	Time	Method
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.	12 months
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.	12 months

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States