Clinical Trial Finder

Inclusion Criteria:

• - Subjects must have histologically confirmed diagnosis of a non-small cell lung cancer, breast cancer, melanoma or renal cell cancer primary.

• - Subjects must have >5 contrast-enhancing lesions, never previously treated with SRS and/or surgical resection, on a contrast-enhanced T1-weighted brain MRI performed within two weeks of enrollment, with at least one lesion >0.5cm in greatest dimension.

• - Physical examination by a radiation oncologist or medical oncologist within 14 days of the start of WBRT.

• - Plan to be treated with WBRT to a dose of 30 Gy in 10 fractions.

• - Age * 18 years.

• - Karnofsky Performance Status (KPS) ≥ 70.

• - Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 cells/*l, platelets ≥ 125,000 cells/*l.

• - Serum creatinine ≤ 1.5 mg/dl, serum SGOT and bilirubin ≤ 1.5 times upper limit of normal.

• - Signed informed consent approved by the Institutional Review Board.

• - If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 6 months afterwards as stated in the informed consent.

• - Able to provide study specific informed consent.

• - Willing to follow study procedures, complete QOL questionnaires and neurocognitive testing as described in the protocol.

• - Negative serum pregnancy test for women of child bearing potential within 48 hours of first dose of BMX.

Exclusion Criteria:

• - Active infection requiring IV antibiotics 7 days before enrollment.

• - Hypertension requiring 3 or more anti-hypertensive medications to control.

• - Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.

• - History of syncope within the last 6 months.

• - Subjects receiving prohibited medications listed in Section 6.4.

2 of this protocol are not eligible. Subjects who can safely stop taking a prohibited medication at least 7 days prior to the first dose of BMX may participate at the discretion of the treating physician.

• - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

• - Women who are breast feeding.

• - Known hypersensitivity to compounds of similar chemical composition to BMX-001.

• - Prior surgical resection for brain metastases and/or stereotactic radiosurgery for up to 5 brain metastases in total are permitted if performed at least 1 month prior to planned WBRT under this protocol.

• - Prior whole brain radiation therapy.

- Patients with diffuse leptomeningeal disease (carcinomatous meningitis) - A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) - A history of additional risk factors for TdP (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome)

This protocol is for a Phase 1 safety lead-in clinical trial of BMX-001 in combination with WBRT in 5 patients with MBM. Demonstrating safety of the selected MTD of BMX-001 in patients with MBM undergoing standard protocol WBRT will be the "go/no-go" criteria for proceeding to Phase 2. Phase 2 is a randomized open-label Phase 2 clinical trial of 64 patients with MBM, half receiving BMX-001 in combination with WBRT and half receiving WBRT alone. Subjects are treated with BMX-001 for a total of 19 days, during which time they receive radiation therapy. Following completion of radiation therapy, subjects will be followed for an additional one year.

Arms

Active Comparator: WBRT + BMX-001

Whole brain radiation therapy in combination with BMX-001 (subcutaneous injection of 28 mg loading dose, followed by subsequent 14 mg twice per week for 2 weeks).

No Intervention: Whole Brain Radiation Therapy

Whole brain radiation therapy per standard of care.

Interventions

Drug: - BMX-001

Manganese butoxyethyl pyridyl porphyrin

Radiation: - Whole Brain Radiation Therapy

Whole Brain Radiation Therapy per standard of care.