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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00946673
Collaborator
National Comprehensive Cancer Network (Other)
17
Enrollment
2
Locations
1
Arm
73
Duration (Months)
8.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: vorinostat & stereotactic radiosurgery

Drug: Vorinostat
Orally up to 400 mg

Procedure: Radiation Therapy
Single fraction stereotactic radiotherapy - Standard of Care

Outcome Measures

Primary Outcome Measures

  1. The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined. [30 days following Stereotactic Radiosurgery]

  2. 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]

  3. 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]

Secondary Outcome Measures

  1. The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined. [12 months]

  2. The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Stanford California United States 94305
2 Moffitt Cancer Center Tampa Florida United States 33612

Sponsors and Collaborators

  • Stanford University
  • National Comprehensive Cancer Network

Investigators

  • Principal Investigator: Griffith R. Harsh, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Griffith R Harsh, Professor of Neurosurgery, Stanford University
ClinicalTrials.gov Identifier:
NCT00946673
Other Study ID Numbers:
  • LUN0036
First Posted:
Jul 27, 2009
Last Update Posted:
Oct 6, 2017
Last Verified:
Oct 1, 2017
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Vorinostat

Study Results

No Results Posted as of Oct 6, 2017