Brain EdemaPhase 3NCT00226655
An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
A Phase 3 study testing hCRF [XERECEPT (corticorelin acetate injection)] in people with Brain Edema and Brain Tumor, run by Celtic Pharma Development Services at 32 sites in 2 countries.
Trial summary
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat 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 [XERECEPT (corticorelin acetate injection)]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Jul 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
- Have a Karnofsky Performance of > 50 at Baseline
- Capable of self-administration of subcutaneous injections twice daily 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 Baseline
Who cannot join
- Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
- Systemic steroid use for any indication other than peritumoral brain edema.
- Use or intended use of dexamethasone as an anti-emetic during study.
- 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 during study participation.
- Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
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- 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 (CNS) infection.
- Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States25 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 Medical Center
Boston, Massachusetts, 02215
Feinberg School of Medicine, Northwestern University
Chicago, Illinois, 60611
University Hematology Oncology Care, LLC
Cincinnati, Ohio, 43210
Good Samaritan Hospital
Cincinnati, Ohio, 45220
The Ohio State University
Columbus, Ohio, 43210
Hermelin Brain Tumor Center, Henry Ford Hospital
Detroit, Michigan, 48202
Colorado Neurological Institute Center for Brain & Spinal Tumors
Englewood, Colorado, 80113
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Mayo Clinic
Jacksonville, Florida, 32224
University of Wisconsin
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Weill Medical College of Cornell University
New York, New York, 10021
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Cancer Institute of Orlando
Orlando, Florida, 32804
Stanford University Medical Center
Palo Alto, California, 94305
Barrow Neurological Institute
Phoenix, Arizona, 85013
Oregon Clinic
Portland, Oregon, 97210
UC Davis Medical Center, Division of Medical Oncology
Sacramento, California, 95817
UC San Diego Cancer Center
San Diego, California, 92037
Virginia Mason Clinic
Seattle, Washington, 98111
Moffitt Cancer Center
Tampa, Florida, 33612
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1ZT
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
Caner Centre of Southwestern Ontario/ Kingston General Hospital
Kingston, Ontario, K7L 5P9
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Ottawa Regional Cancer Center
Ottawa, Ontario, K1H 1C4
Sunnybrook and Women's College Health Sciences Center
Toronto, Ontario, M4N 3M5
CancerCare Manitoba
Winnipeg, Manitoba, MB R3E 0V9
About this study
Official title: An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
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 [XERECEPT (corticorelin acetate injection)]
- 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.
hCRF [XERECEPT (corticorelin acetate injection)]Drug
Also called hCRF, XERECEPT (corticorelin acetate injection)
2mg/day
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | All patients will receive hCRF (XERECEPT) 2mg/day Receives: Drug: hCRF [XERECEPT (corticorelin acetate injection)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Term Safety and Tolerability of hCRF
Number of patients reporting adverse events
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 startJul 2005
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celtic Pharma Development Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurobiological Technologies
- Responsible party
- Sponsor
- Investigators
- William Shapiro, MD, Principal investigator, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226655
- Sponsor's protocol ID
- NTI 0501
- Status last verified
- Jul 2012
- First submitted
- 23 Sep 2005
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies
- ClinicalTrials.gov ID
- NCT00226655
- Acronym / sponsor ID
- NTI 0501
- 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
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Celtic Pharma Development ServicesIndustry (pharma, biotech, devices)
- Collaborators
- Neurobiological Technologies
- Study start
- Jul 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Posted 31 Aug 2012
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 long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: hCRF [XERECEPT (corticorelin acetate injection)]All patients will receive hCRF (XERECEPT) 2mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
- Have a Karnofsky Performance of > 50 at Baseline
- Capable of self-administration of subcutaneous injections twice daily 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 Baseline
Key exclusion criteria (9 listed)
- Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
- Systemic steroid use for any indication other than peritumoral brain edema.
- Use or intended use of dexamethasone as an anti-emetic during study.
- 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 during study participation.
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 |
|---|---|---|
| hCRF [XERECEPT (corticorelin acetate injection)]Also: hCRF, XERECEPT (corticorelin acetate injection)2mg/day | Drug | I |
Primary outcome
Long Term Safety and Tolerability of hCRF
Time frame: Prospective
Number of patients reporting adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
32 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 [XERECEPT (corticorelin acetate injection)] in people with Brain Edema and Brain Tumor, run by Celtic Pharma Development Services at 32 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 9 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: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Long Term Safety and Tolerability of hCRF (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 31 Aug 2012.