Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2017-11-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: Spectrum Pharmaceuticals, Inc
• Treatments: Lucanthone

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.