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A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain Cancer, Neoplasm Metastasis, Lung Cancer, Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.

Outcome Time Frame:

30 days following Stereotactic Radiosurgery

Safety Issue:

Yes

Principal Investigator

Griffith R. Harsh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

LUN0036

NCT ID:

NCT00946673

Start Date:

June 2009

Completion Date:

June 2015

Related Keywords:

  • Brain Cancer
  • Neoplasm Metastasis
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Brain Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317
Moffitt Cancer Center Tampa, Florida  33612