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:
Stanford University
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
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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:
Genetics Home Reference related topics:
lung cancer
Drug Information available for:
Vorinostat
U.S. FDA Resources
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 (Adult, Senior) |
| 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
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
| 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:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Vorinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016