Peritumoral Brain EdemaPhase 2NCT00691522
Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)
A Phase 2 study testing Xerecept in people with Peritumoral Brain Edema and PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS, run by PharmaNet.
Trial summary
This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peritumoral Brain Edema, PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS
- What is being tested?
- Xerecept
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Oct 2009
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Written informed consent has been provided and documented.
- Primary malignant or metastatic brain tumor that is either asymptomatic or symptomatic patients with the life expectancy estimation of 3 months or more
- A pretreatment MRI brain scan must identify at least 1 dominant tumor lesion and related PBE that is radiologically (or visibly) distinct from the main tumor mass; the combined tumor-edema lesion must be > 2 cm in longest diameter (for at least 1 slice) and visible in 3 consecutive, 4 mm sections on MRI.
- No dexamethasone or anti-angiogenic treatment for at least 14 days prior to the Baseline and throughout the study.
- A Karnofsky Performance Score > 60 at Screening (Visit 1) and at Baseline
- A negative serum pregnancy test at the Screening (Visit 1) is required for women of childbearing potential.
Who cannot join
- • Low-grade gliomas, recurrent gliomas, suspected lymphoma, or known human immunosuppressive virus (HIV) infection.
- Patients requiring surgery, radiosurgery or radiation surgery therapy
- Patients experiencing severe symptoms related to PBE
- Patients where MRI is contraindicated for any reason.
- Signs and/or symptoms of relatively severe cerebral herniation.
- Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the 3 to 4 weeks of study treatment.
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- Systemic corticosteroid use (with the exception of inhalers for asthma).
- Use of dexamethasone (eg, as an anti-emetic) during screening or during the study
- Use of anti-angiogenic/anti-vascular endothelial growth factor (VEGF) therapy or anticonvulsant therapy (if patient's liver function tests (LFTs) are > 3 times upper limit of normal) 14 days prior to randomization
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal, or endocrine metabolic disease, which in the opinion of the Investigator or the Medical Monitor, would put the patient as unusual risk during study participation.
- Known renal insufficiency or screening glomerular filtration rate (GFR) < 60 mL/min/1.73 m2.
- Central nervous system infection, human immunosuppressive virus (HIV) positive or ongoing infectious process.
- For female patients: pregnancy, breastfeeding or refusal to practice birth control if of childbearing potential during the study.
- Inability of the patient to follow the treatment regimen.
- Known history of methionine allergy.
About this study
Official title: Open-Label, Imaging Study of Human Corticotropin-Releasing Factor (hCRF) for The Reduction of Peritumoral Brain Edema (PBE) in Patients With Primary Malignant or Metastatic Brain Tumors
This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days
Read the detailed description
The purpose of this study is to investigate the effect of 3 different regimens of subcutaneous (SC) administered hCRF (1.0 mg every [Q] 8 hours [h], 1.5 mg Q12h, and 1.0 mg Q12h) on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes.
- Being tested
- Xerecept
- Keywords
- PERITUMORAL BRAIN EDEMA, PRIMARY MALIGNANT BRAIN TUMORS, METASTATIC BRAIN TUMORS
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XereceptDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritumoral 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaNet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celtic Pharma Development Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691522
- Sponsor's protocol ID
- CPDS 0701
- Status last verified
- Jan 2009
- First submitted
- 2 Jun 2008
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Imaging Study of Human Corticotropin-Releasing Factor (hCRF) for The Reduction of Peritumoral Brain Edema (PBE) in Patients With Primary Malignant or Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT00691522
- Acronym / sponsor ID
- CPDS 0701
- Keywords
- PERITUMORAL BRAIN EDEMA, PRIMARY MALIGNANT BRAIN TUMORS, METASTATIC BRAIN TUMORS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PharmaNetIndustry (pharma, biotech, devices)
- Collaborators
- Celtic Pharma Development Services
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 5 Jun 2008 (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.
This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days
Detailed description
The purpose of this study is to investigate the effect of 3 different regimens of subcutaneous (SC) administered hCRF (1.0 mg every [Q] 8 hours [h], 1.5 mg Q12h, and 1.0 mg Q12h) on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older.
- Written informed consent has been provided and documented.
- Primary malignant or metastatic brain tumor that is either asymptomatic or symptomatic patients with the life expectancy estimation of 3 months or more
- A pretreatment MRI brain scan must identify at least 1 dominant tumor lesion and related PBE that is radiologically (or visibly) distinct from the main tumor mass; the combined tumor-edema lesion must be > 2 cm in longest diameter (for at least 1 slice) and visible in 3 consecutive, 4 mm sections on MRI.
- No dexamethasone or anti-angiogenic treatment for at least 14 days prior to the Baseline and throughout the study.
Key exclusion criteria (15 listed)
- • Low-grade gliomas, recurrent gliomas, suspected lymphoma, or known human immunosuppressive virus (HIV) 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 |
|---|---|---|
| Xerecept | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xerecept in people with Peritumoral Brain Edema and PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS, run by PharmaNet.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early. Results are not available in the source record.
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.
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 9 Jan 2009.