Protocol Title:

A Phase III Randomized open label comparative study of whole brain radiation therapy with supplemental oxygen with or without concurrent RSR 13 (efaproxiral) in women with brain metastasis from breast cancer

Protocol Status:

Closed

Protocol Number:

J0535

Type of Cancer:

Brain metastasis from Breast cancer

Principal Investigator :

Lawrence Kleinberg, MD

Research Nurse:

Shirl DiPasquale, RN

Phase Number:

III

General Eligibility:

Confirmed breast cancer in women with radiographically confirmed mets to brain. May have dural lesions, proof of onset after primary diagnosis of breast cancer; may have extracranial mets; may have received prior treatment for breast cancer and extracranial mets; may receive concurrent trastuzumab (Herceptin); hormonal and/ or corticosteroid therapy.
Must be at least 18 y.o. Have a KPS > 70; adequate hematologic,(hgb>10 g/dl; WBC >. 2500 ; ANC >1500; plt .> 100,000) hepatic and renal function (serum creatinine < 1.5 the ULN; AST (SGOT) and ALT(SGPT) < 3 times the ULN
Adequate pulmonary function FVC and FEV > 50% of normal for that patient
Resting SPO2 > 90% while breathing room air exercise SPO > 90% (walk 50 feet)
Cannot be pregnant, must be accessible for repeat dosing and follow up

Purpose:

To determine the effect of efaproxiral on primary and secondary endpoints in patients with brain metastasis from breast cancer receiving daily intravenous efaproxiral with supplemental oxygen administered prior to receiving standard whole brain radiation (WBRT)therapy compared to patients receiving standard WBRT with supplemental oxygen alone.

Treatment:

Patients randomized to treatment arm A will receive daily efaproxiral and supplemental oxygen within 30 minutes prior to daily WBRT. Those randomized to treatment arm B will receive supplemental oxygen and WBRT.