Brain Edema, Brain Tumor
Conditions
Keywords
peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
Brief 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. 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.
Interventions
DRUGhCRF [XERECEPT (corticorelin acetate injection)]
2mg/day
Sponsors
Neurobiological Technologies
Celtic Pharma Development Services
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long Term Safety and Tolerability of hCRF | Prospective | Number of patients reporting adverse events |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment started February 2005;
Pre-assignment details
Patients rolled-over from previous placebo controlled studies; open label study so no group assignment
Participants by arm
| Arm | Count |
|---|---|
| hCRF All patients will receive hCRF (XERECEPT) 2mg/day | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 35 |
| Overall Study | Clinical deterioration | 10 |
| Overall Study | Death | 13 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | hCRF |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants |
| Age Continuous | 51.4 years STANDARD_DEVIATION 11 |
| Region of Enrollment Australia | 4 participants |
| Region of Enrollment Canada | 6 participants |
| Region of Enrollment New Zealand | 1 participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 111 / 112 |
| serious Total, serious adverse events | 72 / 112 |
Outcome results
Primary
Long Term Safety and Tolerability of hCRF
Number of patients reporting adverse events
Time frame: Prospective
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| hCRF | Long Term Safety and Tolerability of hCRF | 111 Participants | 4.5 |