Open-Label, Imaging Study of Human Corticotropin-Releasing Factor (hCRF) for The Reduction of Peritumoral Brain Edema (PBE) in Patients With Primary Malignant or Metastatic Brain Tumors
- 18 years of age or older.
- Written informed consent has been provided and documented.
- Primary malignant or metastatic brain tumor that is either asymptomatic or
symptomatic patients with the life expectancy estimation of 3 months or more
- A pretreatment MRI brain scan must identify at least 1 dominant tumor lesion and
related PBE that is radiologically (or visibly) distinct from the main tumor mass;
the combined tumor-edema lesion must be > 2 cm in longest diameter (for at least 1
slice) and visible in 3 consecutive, 4 mm sections on MRI.
- No dexamethasone or anti-angiogenic treatment for at least 14 days prior to the
Baseline and throughout the study.
- A Karnofsky Performance Score > 60 at Screening (Visit 1) and at Baseline
- A negative serum pregnancy test at the Screening (Visit 1) is required for women of
- • Low-grade gliomas, recurrent gliomas, suspected lymphoma, or known human
immunosuppressive virus (HIV) infection.
- Patients requiring surgery, radiosurgery or radiation surgery therapy
- Patients experiencing severe symptoms related to PBE
- Patients where MRI is contraindicated for any reason.
- Signs and/or symptoms of relatively severe cerebral herniation.
- Concurrent enrollment in any other investigational drug or device study, or plan
to enroll in such a study during the 3 to 4 weeks of study treatment.
- Systemic corticosteroid use (with the exception of inhalers for asthma).
- Use of dexamethasone (eg, as an anti-emetic) during screening or during the
- Use of anti-angiogenic/anti-vascular endothelial growth factor (VEGF) therapy or
anticonvulsant therapy (if patient's liver function tests (LFTs) are > 3 times
upper limit of normal) 14 days prior to randomization
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal, or
endocrine metabolic disease, which in the opinion of the Investigator or the
Medical Monitor, would put the patient as unusual risk during study
- Known renal insufficiency or screening glomerular filtration rate (GFR) < 60
- Central nervous system infection, human immunosuppressive virus (HIV) positive
or ongoing infectious process.
- For female patients: pregnancy, breastfeeding or refusal to practice birth
control if of childbearing potential during the study.
- Inability of the patient to follow the treatment regimen.
- Known history of methionine allergy.