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

This study has been withdrawn prior to enrollment.

( Alternate study projected to assess imaging endpoints versus clinical endpoints. )

First Received on September 23, 2005. Last Updated on December 27, 2007 History of Changes

Sponsor:	Celtic Pharma Development Services
Collaborator:	Neurobiological Technologies
Information provided by:	Celtic Pharma Development Services
ClinicalTrials.gov Identifier:	NCT00226668

Purpose

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.

Condition	Intervention	Phase
Brain Edema Brain Tumor	Drug: hCRF Drug: placebo hCRF	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Edema

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Corticorelin acetate Dexamethasone Sodium Phosphate Corticotropin Corticotropin-releasing hormone

U.S. FDA Resources

Further study details as provided by Celtic Pharma Development Services:

Primary Outcome Measures:

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. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2008

Arms	Assigned Interventions
Experimental: I Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking	Drug: hCRF hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking Other Name: XERECEPT (corticorelin acetate injection)
Placebo Comparator: II Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking	Drug: placebo hCRF placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking Other Name: placebo XERECEPT (corticorelin acetate injection)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226668

Show 26 Study Locations

Sponsors and Collaborators

Celtic Pharma Development Services

Neurobiological Technologies

Investigators

Principal Investigator:

William Shapiro, MD

Barrow Neurological Institute

More Information

No publications provided

Responsible Party:	Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services
ClinicalTrials.gov Identifier:	NCT00226668 History of Changes
Other Study ID Numbers:	NTI 0302, corticorelin acetate injection
Study First Received:	September 23, 2005
Last Updated:	December 27, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celtic Pharma Development Services:

peritumoral brain edema
edema
malignant brain tumor
astrocytoma

brain tumor
dexamethasone
Decadron

Additional relevant MeSH terms:

Brain Edema
Brain Neoplasms
Edema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Signs and Symptoms
Corticotropin-Releasing Hormone
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate

BB 1101
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012