Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)
Information source: PharmaNet
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peritumoral Brain Edema; PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS
Intervention: Xerecept (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: PharmaNet Official(s) and/or principal investigator(s):
Ann Sysel, MD, Study Director, Affiliation: PharmaNet
Overall contact:
Ann Sysel, MD, Phone: 609-951-6735, Email: asysel@pharmanet.com
Summary
This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in
patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients
will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To investigate the effect of 3 different regimens SC of hCRF on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes.
Secondary outcome: To evaluate the safety of hCRF in the treatment of PBE patients with primary malignant or metastatic brain tumors
To establish the percentage of responders as measured by clinical and radiographic means
To identify tumor and PBE changes
Detailed description:
The purpose of this study is to investigate the effect of 3 different regimens of
subcutaneous (SC) administered hCRF (1. 0 mg every [Q] 8 hours [h], 1. 5 mg Q12h, and 1. 0 mg
Q12h) on the reduction of PBE in patients with primary malignant or metastatic brain tumors
as defined by MRI indexes.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
childbearing potential.
Exclusion Criteria:
- • 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
study
- 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
participation.
- Known renal insufficiency or screening glomerular filtration rate (GFR) < 60
mL/min/1. 73 m2.
- 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.
Locations and Contacts
Ann Sysel, MD, Phone: 609-951-6735, Email: asysel@pharmanet.com
University of Alabama, Birmingham, Alabama 35294-3410, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States
UCLA Medical Center, Los Angeles, California 90095, United States
Cedars-Sinai Medical Center, Angeles, California 90048, United States
University of California San Diego Medical Center, La Jolla, California 92037-0845, United States
Stanford University-Stanford Neurosurgery, Stanford, California 94305, United States
H. Lee Moffit Cancer Center & Research Institute, Tampa, Florida 33612, United States
University of Illinois at Chicago (UIC), Chicago, Illinois 60612, United States
Boston Medical Center & Boston University School of Medicine, Boston, Massachusetts 02118, United States
Beth Israel Deacones Medical Center, Boston, Massachusetts 02215, United States
The Clinical Research Institute at Research Medical Center, Kansas City, Missouri 64132, United States
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Dent Neurologic Institute, Amherst, New York 14226, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10010, United States
New York Presbyterian-Weill Cornell Medical College, New York, New York 10010, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States
Cleveland Clinic-Brain Tumor & Neuro-Oncology Center, Cleveland, Ohio 44195, United States
Fox Chase Cancer Center and Temple University, Philadelphia, Pennsylvania 19140, United States
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington 98195, United States
Additional Information
Starting date: November 2008
Ending date: October 2009
Last updated: September 25, 2008
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