A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

Celtic Pharma Development Services34 sites in 2 countries200 target enrollmentMay 2004

ConditionsBrain Edema Brain Tumor

InterventionshCRF placebo hCRF

DrugshCRF placebo hCRF

Overview

Phase: Phase 3
Intervention: hCRF
Conditions: Brain Edema
Sponsor: Celtic Pharma Development Services
Enrollment: 200
Locations: 34
Primary Endpoint: The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

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.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

March 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Celtic Pharma Development Services

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

I

Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.

Intervention: hCRF

II

Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking

Intervention: placebo hCRF

Outcomes

Primary Outcomes

The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5

Time Frame: Prospective

The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following: * 50% or greater reduction in dexamethasone dose relative to Baseline * Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline * Karnofsky Score unchanged or increased relative to Baseline

Secondary Outcomes

Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS(Prospective)
The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8(Prospective)
Change From Baseline in the Karnofsky Performance Score(Prospective)
Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)(Prospective)
Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study(Prospective)
Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)(Prospective)
Change From Baseline in the FACT-Br Quality of Life Results(Prospective)
Number of Patients Who Discontinued Study Drug Prior to the End of Week 5(Prospective)