Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02014545|
Recruitment Status : Withdrawn (Pending resolution of study drug issues)
First Posted : December 18, 2013
Last Update Posted : July 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases Non-small Cell Lung Cancer||Drug: Lucanthone Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase II Trial Evaluating the Addition of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||November 29, 2017|
|Actual Study Completion Date :||November 29, 2017|
Active Comparator: WBRT + Lucanthone
Treatment will consist of WBRT given in a dose of 30 Gy in ten fractions with lucanthone given as an adjunct. Lucanthone will be administered as 25 mg and 100 mg tablets to be swallowed. Dosage will be one of the following: 250 mg bid, 250 tid, or 375 mg tid.
The dose of lucanthone to be administered will be calculated based on the patient's body weight. The dose to be given will be 250 bid, 250 tid or 375 tid dependent upon study progression.
Placebo Comparator: WBRT + Placebo
Patients will receive prophylactic cranial irradiation at 3 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 30 Gy.
Only standard treatment of whole brain radiation therapy is done.
- Determine the efficacy of lucanthone when given during WBRT [ Time Frame: 2 weeks to 13 months ]Progression free survival at 6 months and one year, overall response rate at months 1, 4, 7, 10, and 13 months and overall survival at 13 months will be evaluated. MRI brain scans will be performed baseline and months 1, 4, 7, 10, and 13. Objective assessments of overall response will be based on tumor assessments from MRI scans interpreted using the Revised Assessment in Neuro-Oncology (RANO) criteria.
- Evaluate the safety and toxicity of lucanthone when used in combination with standard doses of WBRT in the primary treatment of brain metastases secondary to non-small cell lung cancer [ Time Frame: 2 weeks to 13 months ]Safety will be monitored throughout the study by physical exams, review of adverse events, and laboratory studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014545
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Stefan C. Grant, MD, JD||Wake Forest University Health Sciences|