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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2024-04-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Brain Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

BMX-001

Intervention Type DRUG

Manganese butoxyethyl pyridyl porphyrin

Whole Brain Radiation Therapy

Intervention Type RADIATION

Whole Brain Radiation Therapy per standard of care.

Whole Brain Radiation Therapy

Whole brain radiation therapy per standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BMX-001

Manganese butoxyethyl pyridyl porphyrin

Intervention Type DRUG

Whole Brain Radiation Therapy

Whole Brain Radiation Therapy per standard of care.

Intervention Type RADIATION

Other Intervention Names

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Whole Brain Radiation Therapy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No