Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified September 2012 by Stanford University
Sponsor:
Griffith R Harsh
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 6, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | June 2015 |
| Estimated Primary Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946673
Contacts
| Contact: Maria Coburn | (650) 736-9551 | mcoburn@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Maria Coburn 650-736-9551 mcoburn@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Sub-Investigator: Clara Choi | |
| Sub-Investigator: Iris Catrice Gibbs | |
| Sub-Investigator: Scott Soltys | |
| Sub-Investigator: Heather A. Wakelee | |
| Principal Investigator: Griffith R. Harsh | |
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Melissa Joiner, RN, CCRC 813-745-1896 Melissa.joiner@moffitt.org@moffitt.org | |
| Principal Investigator: Mary Pinder-Schenck, MD | |
Sponsors and Collaborators
Griffith R Harsh
National Comprehensive Cancer Network
Investigators
| Principal Investigator: | Griffith R. Harsh | Stanford University |
More Information
No publications provided
| Responsible Party: | Griffith R Harsh, Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00946673 History of Changes |
| Other Study ID Numbers: | LUN0036 |
| Study First Received: | July 23, 2009 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013