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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00892801 |
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus and to see how well it works when given together with whole-brain radiation therapy in treating patients with brain metastasis from non-small cell lung cancer.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Lung Cancer |
Drug: everolimus Radiation: whole-brain radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of RAD001 and Radiation Therapy in Patients With Brain Metastasis From Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 62 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of everolimus.
Patients undergo 10 fractions of whole-brain radiotherapy (WBRT) beginning on day 0, 5 days per week, and receive oral everolimus once daily on days -1 to 13. Beginning 2 weeks after completion of WBRT, patients receive oral everolimus once daily for 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, including any of the following:
PRIOR CONCURRENT THERAPY:
Prior surgical resection of a brain metastasis allowed
Responsible Party: | Vanderbilt-Ingram Cancer Center ( Bo Lu ) |
Study ID Numbers: | CDR0000641751, VU-VICC-THO-0772, IRB#090314 |
Study First Received: | May 2, 2009 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00892801 History of Changes |
Health Authority: | Unspecified |
adult tumors metastatic to brain recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Everolimus Immunologic Factors Central Nervous System Neoplasms Immunosuppressive Agents Recurrence Carcinoma Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Everolimus Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Central Nervous System Neoplasms Immunosuppressive Agents Pharmacologic Actions Carcinoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |