Back to resultsEvaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
Primary Purpose
Brain Metastases, Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lucanthone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases focused on measuring brain metastases, non-small cell lung cancer, whole brain radiation therapy, lucanthone
Eligibility Criteria
Inclusion Criteria:
- The patient has given informed consent.
- The patient is willing and able to abide by the protocol.
- The patient is between age 18 and 70 (between 19 and 70 in Alabama).
- The patient has histologically proven NSCLC with radiologically documented brain metastases.
- Newly diagnosed or stable systemic disease, on or off systemic therapy.
- If receiving systemic therapy for NSCLC, at least two weeks since patient received systemic therapy.
- Able to withhold systemic therapy for duration of WBRT therapy.
- If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception.
- The patient's Karnofsky Score is greater than or equal to 70%.
Exclusion Criteria:
- Patient has a diagnosis of recurrent brain metastases.
- The patient has an absolute neutrophil count less than or equal to 1.5 X 10 9/L.
- The patient has a screening platelet count less than 100,000/uL.
- The patient has a screening bilirubin greater than 1.6 mg/dL.
- The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women.
- The patient has a screening ALT/AST greater than 2.5 times the upper limit of the laboratory reference range.
- The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
- The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
- The patient has received prior chemotherapy or radiation therapy within two weeks of beginning WBRT on protocol.
- The patient is allergic to gadolinium contrast.
- More than 21 days has or will elapse between the brain MRI documenting the brain metastases and the initiation of WBRT.
Sites / Locations
- Comprehensive Cancer Center of Wake Forest University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
WBRT + Lucanthone
WBRT + Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Determine the efficacy of lucanthone when given during WBRT
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.
Secondary Outcome Measures
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
Safety will be monitored throughout the study by physical exams, review of adverse events, and laboratory studies.
Full Information
NCT ID
NCT02014545
First Posted
December 12, 2013
Last Updated
July 3, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
Spectrum Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02014545
Brief Title
Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Pending resolution of study drug issues
Study Start Date
January 2016 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Spectrum Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double blind placebo controlled study to evaluate safety and efficacy of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.
Detailed Description
Eligible patients for this trial will be randomized to lucanthone or placebo in a ratio of 1:1. The treatment will consist of WBRT given in a dose of 30 Gy in ten fractions. Lucanthone/placebo will be given as an adjunct to the WBRT on days that WBRT is administered. Tumor assessments will be done with a brain MRI. Radiological assessments on the tumor will be made periodically throughout the study and will be discontinued at the time of tumor progression. Safety will be evaluated for one year during the study period and survival data will be collected thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Non-small Cell Lung Cancer
Keywords
brain metastases, non-small cell lung cancer, whole brain radiation therapy, lucanthone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WBRT + Lucanthone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
WBRT + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lucanthone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Only standard treatment of whole brain radiation therapy is done.
Primary Outcome Measure Information:
Title
Determine the efficacy of lucanthone when given during WBRT
Description
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.
Time Frame
2 weeks to 13 months
Secondary Outcome Measure Information:
Title
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
Description
Safety will be monitored throughout the study by physical exams, review of adverse events, and laboratory studies.
Time Frame
2 weeks to 13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has given informed consent.
The patient is willing and able to abide by the protocol.
The patient is between age 18 and 70 (between 19 and 70 in Alabama).
The patient has histologically proven NSCLC with radiologically documented brain metastases.
Newly diagnosed or stable systemic disease, on or off systemic therapy.
If receiving systemic therapy for NSCLC, at least two weeks since patient received systemic therapy.
Able to withhold systemic therapy for duration of WBRT therapy.
If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception.
The patient's Karnofsky Score is greater than or equal to 70%.
Exclusion Criteria:
Patient has a diagnosis of recurrent brain metastases.
The patient has an absolute neutrophil count less than or equal to 1.5 X 10 9/L.
The patient has a screening platelet count less than 100,000/uL.
The patient has a screening bilirubin greater than 1.6 mg/dL.
The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women.
The patient has a screening ALT/AST greater than 2.5 times the upper limit of the laboratory reference range.
The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
The patient has received prior chemotherapy or radiation therapy within two weeks of beginning WBRT on protocol.
The patient is allergic to gadolinium contrast.
More than 21 days has or will elapse between the brain MRI documenting the brain metastases and the initiation of WBRT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan C. Grant, MD, JD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
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