An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

Condition(s) targeted: Brain Edema; Brain Tumor

Intervention: hCRF [XERECEPT (corticorelin acetate injection)] (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Celtic Pharma Development Services

Official(s) and/or principal investigator(s):
William Shapiro, MD, Principal Investigator, Affiliation: Barrow Neurological Institute

Overall contact:
Patrick M. Rossi, MD, Phone: (609) 744-3880, Email: patrick.rossi@dev.celticpharma.com

The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

Official title: An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: The study will evaluate the overall long-term safety and tolerability of hCRF and steroid toxicities by monitoring dexamethasone dosing, laboratory values, adverse events,electrocardiograms and neurological and clinical status.

Detailed description: XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participation in and completion of stipulated final follow-up periods for study NTI

0302, NTI 0303, or other designated studies.

- Have a Karnofsky Performance of > 50 at Baseline

- Capable of self-administration of subcutaneous injections twice daily or availability

of assistance from caregiver.

- Ability to provide written informed consent or, if unable to provide, have a legal

guardian or representative provide written informed consent.

- For women of childbearing potential: a negative serum pregnancy test at Baseline

Exclusion Criteria:

- Concurrent enrollment in any investigational drug or device study, other than NTI

0302, NTI 0303, or other designated studies.

- Systemic steroid use for any indication other than peritumoral brain edema.

- Use or intended use of dexamethasone as an anti-emetic during study.

- Clinical signs and symptoms of cerebral herniation.

- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine

metabolic disease which could put the patient at unusual risk during study participation.

- Confounding previous or concurrent neurological disorders that would interfere with

adequate clinical evaluation.

- Clinically significant head injury or chronic seizure disorder, if the condition

results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)

- Central nervous system (CNS) infection.

- Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for

women of childbearing potential.

Patrick M. Rossi, MD, Phone: (609) 744-3880, Email: patrick.rossi@dev.celticpharma.com

Cross Cancer Institute, Edmonton, Alberta T6G1ZT, Canada; Recruiting
Dorcas Fulton, MD, Phone: 780-432-8771, Email: dorcas.fulton@cancerboard.ab.ca
Dorcas Fulton, MD, Principal Investigator

Barrow Neurological Institute, Phoenix, Arizona 85013, United States; Recruiting
William Shapiro, MD, Phone: 602-406-6233, Email: wshapiro@chw.edu
William Shapiro, MD, Principal Investigator

UC San Diego Cancer Center, San Diego, California 92037, United States; Recruiting
Chris Bornhauser, Phone: 858-657-6967, Email: cbornhauser@ucsd.edu
John F. Alksne, MD, Principal Investigator

UC Davis Medical Center, Division of Medical Oncology, Sacramento, California 95817, United States; Recruiting
Nancy Rudisill, RN, MSN, Phone: 916-734-3491, Email: nancy.rudisill@ucdmc.ucdavis.edu
Robert O'Donnelll, MD, Principal Investigator

Stanford University Medical Center, Palo Alto, California 94305, United States; Recruiting
Cathy Recht, RN, Phone: 650-725-8630, Email: cathy.recht@sbcglobal.net
Lawrence Recht, MD, Principal Investigator

Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States; Recruiting
Laura Whitaker, RN, Phone: 949-764-8190, Email: laura.whitaker@hoaghospital.org
Christopher Duma, MD, Principal Investigator

Colorado Neurological Institute Center for Brain & Spinal Tumors, Englewood, Colorado 80113, United States; Recruiting
Carol Greenwald, MD, Phone: 303-806-7418, Email: cgreenwald@thecni.org
Edward Arenson, MD, Principal Investigator

University of Colorado Cancer Center, Aurora, Colorado 80045, United States; Recruiting
Monica Robischon, RN, Phone: 720-848-0661, Email: Monica.Robischon@uchsc.edu
Denise Damek, MD, Principal Investigator

Cancer Institute of Orlando, Orlando, Florida 32804, United States; Recruiting
Sergey Bushnev, MD, Phone: 407-303-5877, Email: sergey.bushnev.md@flhosp.org
Nick Avgeropoulos, MD, Principal Investigator

Moffitt Cancer Center, Tampa, Florida 33612, United States; Recruiting
Shirley Entis, RN, Phone: 813-979-3929, Email: enitssa@moffitt.ucf.edu
Clifford Schold, MD, Principal Investigator

Mayo Clinic, Jacksonville, Florida 32224, United States; Recruiting
Bryan Courtney, Phone: 904-953-6806, Email: coutrney.bryan@mayo.edu
Kurt Jaeckle, MD, Principal Investigator

Winship Cancer Institute, Emory University, Atlanta, Georgia 30322, United States; Recruiting
Jeffrey Olsen, MD, Phone: 404-778-2214
Jeffrey Olsen, MD, Principal Investigator

Feinberg School of Medicine, Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Lilia Gallot, Phone: 312-469-3790, Email: l-gallot@northwestern.edu
Jeffrey Raizer, MD, Principal Investigator

Evanston Northwestern Healthcare, Evanston, Illinois 60201, United States; Recruiting
Patricia Lada, RN, Phone: 847-570-2025, Email: plada@enh.org
Nina Paleologos, MD, Principal Investigator

CancerCare Manitoba, Winnipeg, Manitoba MB R3E 0V9, Canada; Recruiting
David Eisenstat, MD, Phone: 204-787-2190, Email: eisensta@cc.umanitoba.ca
David Eisenstat, MD, Principal Investigator

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Loretta Barron, RN, Phone: 617-667-1665, Email: lbarron@caregroup.harvard.edu
Eric Wong, MD, Principal Investigator

Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Lindsey McCormick, Phone: 313-916-2158, Email: lmccorm1@hfhs.org
Tom Mikkelson, MD, Principal Investigator

The Moncton Hospital, Moncton, New Brunswick E1C 6Z8, Canada; Recruiting
Anita Ritchie, RN, Phone: 506-860-2219, Email: anritchi@serha.ca
Dhany Charest, MD, Principal Investigator

Memorial Sloan Kettering Cancer Center, New York, New York 10021, United States; Recruiting
Chanda Delgado, Phone: 646-227-2267, Email: delgadc@MSKCC.org
Adilia Hormigo, MD, Principal Investigator

Dent Neurologic Institute, Amherst, New York 14226, United States; Recruiting
Malika Pasha, Phone: 716-250-2028, Email: mpasha@dentinstitute.org
Laszlo Mechtler, MD, Principal Investigator

Weill Medical College of Cornell University, New York, New York 10021, United States; Recruiting
Susan Pannullo, MD, Phone: 212-746-2438, Email: scp2002@med.cornell.edu
Susan Pannullo, MD, Principal Investigator

Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia B3H 1V7, Canada; Recruiting
Tara Shaw, Phone: 902-473-7896, Email: tara.shaw@cdha.nshealth.ca
Email: liam.mulroy@cdha.nshealth.ca
Liam A. Mulroy, MD, FRCPC, Principal Investigator

University Hematology Oncology Care, LLC, Cincinnati, Ohio 43210, United States; Recruiting
Margie Gerena-Lewis, MD, Phone: 513-558-3251, Email: lewism2@ucmail.uc.edu
Margie Gerena-Lewis, MD, Principal Investigator

The Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Jill Burkhart, Phone: 614-293-5554, Email: Burkhart-1@medctr.osu.edu
Herbert Newton, MD, Principal Investigator

Good Samaritan Hospital, Cincinnati, Ohio 45220, United States; Not yet recruiting
Nancee Albright, Phone: 513-936-5370, Email: Nancee_Albright@trihealth.com
Robert Albright, MD, Principal Investigator

Ottawa Regional Cancer Center, Ottawa, Ontario K1H 1C4, Canada; Recruiting
Nancy Page, RN, Phone: 613-737-7700, Ext: 6866, Email: napage@ohri.ca
Stan Z. Gertler, MD, Principal Investigator

Caner Centre of Southwestern Ontario/ Kingston General Hospital, Kingston, Ontario K7L 5P9, Canada; Recruiting
Christine Maize, Phone: 613-544-2631, Ext: 6611, Email: christine.maize@krcc.on.ca
Yolanda Madernas, MD, Principal Investigator

Sunnybrook and Women's College Health Sciences Center, Toronto, Ontario M4N 3M5, Canada; Recruiting
James Perry, MD, Phone: 416-480-4766, Email: James.Perry@sw.ca
James Perry, MD, Principal Investigator

Oregon Clinic, Portland, Oregon 97210, United States; Recruiting
Susan Staat, RN, Phone: 503-413-8330, Email: sstaat@lhs.org
Leslie McAllister, MD, Principal Investigator

Virginia Mason Clinic, Seattle, Washington 98111, United States; Recruiting
Jill Zeller, RN, Phone: 206-586-6559, Ext: 64841, Email: jill.zeller@vmmc.org
Lynne Taylor,, MD, Principal Investigator

University of Wisconsin, Madison, Wisconsin 53792, United States; Recruiting
Diana Trask, RN, Phone: 608-265-1700, Email: trask@humonc.wisc.edu
Ian H. Robins, MD, Principal Investigator

Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3596, United States; Not yet recruiting
Jo Bergholte, MS, Phone: 414-805-9372, Email: jbergholte@mcw.edu
Mark G Malkin, MD, Principal Investigator

Starting date: July 2005
Ending date: May 2008
Last updated: December 27, 2007