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XERECEPT� (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

Information source: Celtic Pharma Development Services
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Edema; Brain Tumor

Intervention: hCRF (Drug); placebo hCRF (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Celtic Pharma Development Services

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

Summary

The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

Clinical Details

Official title: A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2.

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.

Eligibility

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

Criteria:

Inclusion Criteria:

- Histologically confirmed diagnosis of a primary malignant glioma.

- Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone

treatment.

- If a patient is on dexamethasone for treatment of symptomatic peritumoral brain

edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.

- Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic

technology obtained within 21 days of Baseline.

- Capable of self-administration of subcutaneous injections twice daily for 8 weeks or

availability of assistance from caregiver. Exclusion Criteria:

- Need for surgery, radiosurgery or radiation therapy or the introduction of new

chemotherapeutic regime within 2 weeks of study treatment.

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

- Patients on dexamethasone or anticonvulsant therapy.

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

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

- Central nervous system (CNS) infection.

- Conditions that are considered contradictions for patients to receive niacin

Locations and Contacts

Cross Cancer Institute, Edmonton, Alberta T6G1ZT, Canada

Barrow Neurological Institute, Phoenix, Arizona 85013, United States

UC San Diego Cancer Center, La Jolla, California 92093, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States

Stanford University Medical Center, Palo Alto, California 94305, United States

UC Davis Medical Center, Sacramento, California 95817, United States

University of Colorado Cancer Center, Aurora, Colorado 80045, United States

Moffitt Cancer Center and Research, Tampa, Florida 33612, United States

Winship Cancer Institute, Emory University, Atlanta, Georgia 30322, United States

Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611, United States

Evanston Northwestern Healthcare, Evanston, Illinois 60201, United States

Beth Israel Deaconess Med Center, Boston, Massachusetts 02215, United States

Field Neurosciences Institute, Saginaw, Michigan 48604, United States

Neurology Group of Bergen County, Ridgewood, New Jersey 07450, United States

Dent Neurologic Institute, Amherst, New York 14226, United States

Weill Medical College of Cornell University, New York, New York 10021, United States

Wake Forest University, Winston-Salem, North Carolina 27106, United States

Good Samaritan Hospital, Cincinnati, Ohio 45220, United States

University Hematology Oncology Care, LLC, Cincinnati, Ohio 43210, United States

The Ohio State University, Columbus, Ohio 43210, United States

Ottawa Regional Cancer Centre, Ottawa, Ontario K1H 1C4, Canada

Oregon Clinic, Portland, Oregon 97210, United States

Methodist Healthcare - University Hospital, Memphis, Tennessee 38103, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

University of Wisconsin, Madison, Wisconsin 53792, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3596, United States

Additional Information

Starting date: January 2006
Last updated: December 27, 2007

Page last updated: August 20, 2015

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