Status:
COMPLETED
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Lead Sponsor:
Celtic Pharma Development Services
Collaborating Sponsors:
Neurobiological Technologies
Conditions:
Brain Edema
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at ...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00088166
Start Date
May 1 2004
End Date
March 1 2008
Last Update
August 13 2014
Active Locations (34)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
UCSF Fresno Center for Clinical Studies
Fresno, California, United States, 93702
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
4
Stanford University Medical Center
Palo Alto, California, United States, 94305