Completed

A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

hCRF

+ placebo hCRF

Drug
Who is being recruted

Brain Diseases+7

+ Brain Edema

+ Brain Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorCeltic Pharma Development Services
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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

Official TitleA Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone 
NCT00091013NCT00088166
Principal SponsorCeltic Pharma Development Services
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain EdemaBrain NeoplasmsCentral Nervous System DiseasesEdemaNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System Neoplasms

Criteria

Inclusion Criteria: * Histologically confirmed diagnosis of a primary malignant brain tumor or, if metastatic, documentation and histology (if available) of primary source of cancer. * Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline. * Patient has required administration of dexamethasone to control symptoms of peritumoral edema for at least 30 days. * Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline. * Need for administration of dexamethasone to treat peritumoral brain edema (referenced above) has been documented by MRI or comparable diagnostic technology within 21 days of Baseline. * Karnofsky score of \> 50 at Screening and Baseline. * Capable of self-administration of subcutaneous injections twice daily for 12 weeks, 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 Screening. * Must be 18 years of age or older Exclusion Criteria: * Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within the first 5 weeks of study enrollment. Treatment with pre-study chemotherapy may continue. * Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 5 weeks of treatment. * Systemic steroid use for any indication other than peritumoral brain edema. * Use or intended use of dexamethasone as an anti-emetic during Screening or Study * Non-compliance with dexamethasone or anticonvulsant therapy. * 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 for 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 infection. * Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential. * Any conditions that are considered contraindications for patients to receive niacin, e.g. liver disease (with LFTs \> 3 times the upper limit of the norm),active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.

Group II

Placebo
Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 34 locations

Suspended

Barrow Neurological Institute

Phoenix, United StatesSee the location
Suspended

UCSF Fresno Center for Clinical Studies

Fresno, United States
Suspended

Hoag Memorial Hospital Presbyterian

Newport Beach, United States
Suspended

Stanford University Medical Center

Palo Alto, United States
Completed34 Study Centers