Brain MetastasesPhase 2NCT02014545
Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
A Phase 2 study testing Lucanthone in people with Brain Metastases and Non-small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Metastases, Non-small Cell Lung Cancer
- What is being tested?
- Lucanthone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 29 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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%.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Brain Metastases, Non-small Cell Lung Cancer
- Being tested
- Lucanthone, Placebo
- Keywords
- brain metastases, non-small cell lung cancer, whole brain radiation therapy, lucanthone
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucanthoneDrug
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.
PlaceboOther
Only standard treatment of whole brain radiation therapy is done.
| Study group | Role | What they receive |
|---|---|---|
| WBRT + Lucanthone | Active comparator | 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. Receives: Drug: Lucanthone |
| WBRT + Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks to 13 months
Secondary outcomes (1)
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.
Measured: 2 weeks to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2016
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Why it stopped: Pending resolution of study drug issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Spectrum Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Stefan C. Grant, MD, JD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014545
- Sponsor's protocol ID
- IRB00037529
- Other IDs
- IRB00037529
- Status last verified
- Jul 2018
- First submitted
- 12 Dec 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02014545
- Acronym / sponsor ID
- IRB00037529
- Conditions
- Brain Metastases, Non-small Cell Lung Cancer
- Keywords
- brain metastases, non-small cell lung cancer, whole brain radiation therapy, lucanthone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pending resolution of study drug issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Spectrum Pharmaceuticals, Inc
- Study start
- Jan 2016 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBRT + Lucanthone | Active comparator | Drug: LucanthoneTreatment 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. |
| WBRT + Placebo | Placebo comparator | Other: PlaceboPatients will receive prophylactic cranial irradiation at 3 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 30 Gy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LucanthoneThe 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. | Drug | WBRT + Lucanthone |
| PlaceboOnly standard treatment of whole brain radiation therapy is done. | Other | WBRT + Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan C. Grant, MD, JD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lucanthone in people with Brain Metastases and Non-small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of lucanthone when given during WBRT (time frame: 2 weeks to 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.