XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

Celtic Pharma Development Services

Status and phase

Completed

Phase 3

Conditions

Brain Edema

Brain Tumor

Treatments

Drug: hCRF

Drug: placebo hCRF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00088166

NTI 0303

XERECEPT®

Details and patient eligibility

About

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 patients who require chronic high doses of dexamethasone to manage symptoms.

Full description

XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.