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

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

MedlinePlus related topics:

Brain Cancer Cancer Edema

ChemIDplus related topics:

Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Corticotropin Corticotropin-releasing hormone Corticorelin ovine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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
I: Experimental 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
II: Placebo Comparator 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

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

Responsible Party:	Celtic Pharma Development Services ( Patrick Rossi, MD - Medical Monitor )
Study ID Numbers:	NTI 0302, corticorelin acetate injection
First Received:	September 23, 2005
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00226668
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

Study placed in the following topic categories:

Dexamethasone

Corticotropin-Releasing Hormone

Astrocytoma

Edema

Central Nervous System Diseases

Brain Edema

Central Nervous System Neoplasms

Brain Diseases

Adrenocorticotropic Hormone

Brain Neoplasms

Signs and Symptoms

Glioma

Nervous System Neoplasms

Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Nervous System Diseases

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Gastrointestinal Agents

Antiemetics

Glucocorticoids

Hormones

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Celtic Pharma Development Services Neurobiological Technologies
Information provided by:	Celtic Pharma Development Services
ClinicalTrials.gov Identifier:	NCT00226668