A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is for a lead-in safety study of 5 patients followed by a randomized Phase 2 clinical trial of BMX-001, a new class of pharmaceutical, in 64 patients with multiple brain metastases (MBM) undergoing whole brain radiation therapy (WBRT). Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMimetix JV, LLC
• Collaborators: Duke Cancer Institute; National Cancer Institute (NCI)

Criteria

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)