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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Stanford University
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Griffith R Harsh, Stanford University
ClinicalTrials.gov Identifier:
NCT00946673
First received: July 23, 2009
Last updated: September 2, 2014
Last verified: September 2014

July 23, 2009
September 2, 2014
June 2009
December 2014   (final data collection date for primary outcome measure)
  • The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined. [ Time Frame: 30 days following Stereotactic Radiosurgery ] [ Designated as safety issue: Yes ]
  • During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed. [ Time Frame: 30 days following Stereotactic Radiosurgery ] [ Designated as safety issue: Yes ]
  • he radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined. [ Time Frame: 3 months following Stereotactic Radiosurgery ] [ Designated as safety issue: No ]
  • The MTD and DLT of daily vorinostat concurrent with SRS will be determined.
  • The safety of the MTD of vorinostat concurrent with radiotherapy will be confirmed.
  • The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
Complete list of historical versions of study NCT00946673 on ClinicalTrials.gov Archive Site
  • The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
  • The 12-month survival rate from the date of SRS will be determined.
Not Provided
Not Provided
 
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Cancer
  • Neoplasm Metastasis
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Drug: Vorinostat
    Orally up to 400 mg
  • Procedure: Radiation Therapy
    Single fraction stereotactic radiotherapy - Standard of Care
Experimental: vorinostat & stereotactic radiosurgery
Interventions:
  • Drug: Vorinostat
  • Procedure: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
June 2015
December 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Maria Coburn (650) 736-9551 mcoburn@stanford.edu
United States
 
NCT00946673
LUN0036
Not Provided
Griffith R Harsh, Stanford University
Griffith R Harsh
National Comprehensive Cancer Network
Principal Investigator: Griffith R. Harsh Stanford University
Stanford University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP