Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00946673
First received: July 23, 2009
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Brain Cancer
Neoplasm Metastasis
Lung Cancer
Carcinoma, Non-Small-Cell Lung
Drug: Vorinostat
Procedure: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
Study Start Date: June 2009
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vorinostat & stereotactic radiosurgery Drug: Vorinostat
Orally up to 400 mg
Procedure: Radiation Therapy
Single fraction stereotactic radiotherapy - Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946673

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
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
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00946673     History of Changes
Other Study ID Numbers: LUN0036
Study First Received: July 23, 2009
Last Updated: November 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Brain Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Central Nervous System Diseases
Central Nervous System Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Vorinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014