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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Collaborator:
Neurobiological Technologies
Information provided by:
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT00226668
First received: September 23, 2005
Last updated: December 27, 2007
Last verified: December 2007
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Signs and Symptoms
BB 1101
Corticotropin-Releasing Hormone
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014