A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases

Inclusion Criteria

INCLUSION CRITERIA:

- Histologically or cytologically confirmed non-hematopoietic malignancy within the
past 5 years

- If histologic proof of malignancy is from > 5 years ago, then a more recent
pathological confirmation is required (e.g., from systemic metastatic or brain
metastasis)

- Patients with metastasis of unknown primary tumor are permitted

- Measurable brain metastasis outside a 5-mm margin around either hippocampus on
gadolinium contrast-enhanced MRI obtained within the past 30 days

- Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical
resection

- These treatment options are allowed only at relapse

- Patients who have brain metastases at initial presentation allowed and do not need to
demonstrate 3 months of stable scans

- At least 1 week since open biopsy

- Karnofsky performance status 70-100%

- Fertile patients must use effective contraception

- Negative pregnancy test 2 weeks or less prior to study entry

- Patients must be English proficient, with patients who speak English as a second
language eligible

EXCLUSION CRITERIA:

- Small cell lung cancer or germ cell malignancy

- Leptomeningeal metastases

- Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of
extracranial metastases

- Radiologic evidence of hydrocephalus

- Serum creatinine > 1.4 mg/dL within 30 days prior to study entry

- Pregnant or nursing

- Contraindication to MR imaging such as implanted metal devices or foreign bodies or
severe claustrophobia

- Severe, active co-morbidity including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Uncontrolled, clinically significant cardiac arrhythmias

- Prior radiotherapy to the brain

- Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7
days