Brain EdemaPhase 3NCT00226668
XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
A Phase 3 study testing hCRF in people with Brain Edema and Brain Tumor, run by Celtic Pharma Development Services at 26 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Edema, Brain Tumor
- What is being tested?
- hCRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Jan 2006to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States24 sites
Dent Neurologic Institute
Amherst, New York, 14226
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Beth Israel Deaconess Med Center
Boston, Massachusetts, 02215
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
University Hematology Oncology Care, LLC
Cincinnati, Ohio, 43210
Good Samaritan Hospital
Cincinnati, Ohio, 45220
The Ohio State University
Columbus, Ohio, 43210
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
UC San Diego Cancer Center
La Jolla, California, 92093
University of Wisconsin
Madison, Wisconsin, 53792
Methodist Healthcare - University Hospital
Memphis, Tennessee, 38103
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Medical College of Cornell University
New York, New York, 10021
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Stanford University Medical Center
Palo Alto, California, 94305
Barrow Neurological Institute
Phoenix, Arizona, 85013
Oregon Clinic
Portland, Oregon, 97210
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450
UC Davis Medical Center
Sacramento, California, 95817
Field Neurosciences Institute
Saginaw, Michigan, 48604
Moffitt Cancer Center and Research
Tampa, Florida, 33612
Wake Forest University
Winston-Salem, North Carolina, 27106
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1ZT
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
About this 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
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.
Read the 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.
- Conditions
- Brain Edema, Brain Tumor
- Being tested
- hCRF, placebo hCRF
- Keywords
- peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
- Medical subject headings
- Brain Edema, Brain Neoplasms, Edema, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCRFDrug
Also called XERECEPT (corticorelin acetate injection)
hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
placebo hCRFDrug
Also called placebo XERECEPT (corticorelin acetate injection)
placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: hCRF |
| 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 Receives: Drug: placebo hCRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startJan 2006
- Study completionJan 2008 (estimated)
Why it stopped: Alternate study projected to assess imaging endpoints versus clinical endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celtic Pharma Development Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurobiological Technologies
- Investigators
- William Shapiro, MD, Principal investigator, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226668
- Sponsor's protocol ID
- NTI 0302
- Other IDs
- corticorelin acetate injection
- Status last verified
- Dec 2007
- First submitted
- 23 Sep 2005
- Last updated
- 3 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00226668
- Acronym / sponsor ID
- NTI 0302
- Conditions
- Brain Edema, Brain Tumor
- Keywords
- peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Alternate study projected to assess imaging endpoints versus clinical endpoints.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Celtic Pharma Development ServicesIndustry (pharma, biotech, devices)
- Collaborators
- Neurobiological Technologies
- Study start
- Jan 2006
- Study completion
- Jan 2008 (estimated)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: hCRFPatients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking |
| II | Placebo comparator | Drug: placebo hCRFPatients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hCRFAlso: XERECEPT (corticorelin acetate injection)hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking | Drug | I |
| placebo hCRFAlso: placebo XERECEPT (corticorelin acetate injection)placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking | Drug | II |
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.
Time frame: Prospective
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Shapiro, MD principal investigator
Barrow Neurological Institute
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hCRF in people with Brain Edema and Brain Tumor, run by Celtic Pharma Development Services at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2008.