Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02014545 : Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02014545      |      Link to official Clinicaltrials.gov listing
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