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XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
This study has been completed.
Study NCT00088166   Information provided by Celtic Pharma Development Services
First Received: July 20, 2004   Last Updated: March 7, 2008   History of Changes

July 20, 2004
March 7, 2008
May 2004
March 2008   (final data collection date for primary outcome measure)
The proportion of patients in each treatment group who are Responders at Week 2 and continue at Week 5 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
The primary efficacy endpoint is the proportion of reponders, i.e. patients in each treatment group who show improvement at the end of Week 2.
Complete list of historical versions of study NCT00088166 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up visit). [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up visit) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Change from Baseline in the Signal Symptom Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up visit) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Change from Baseline in the FACT-Br quality of life results at Weeks 5, 12 (or Early Study Drug Discontinuation), and 16 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Myopathy assessment results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up visit) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Maximum percent reduction in dexamethasone usage relative to Baseline achieved during the study [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Time to discontinuation of blinded study medication prior to the end of Week 5 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Same as current
 
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
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

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.

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

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Brain Edema
  • Brain Tumor
  • Drug: hCRF
  • Drug: placebo hCRF
  • Experimental: Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
  • Placebo Comparator: Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
220
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00088166
Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services
NTI 0303, XERECEPT®, corticorelin acetate injection
Celtic Pharma Development Services
Neurobiological Technologies
Principal Investigator: William Shapiro, MD Barrow Neurological Institute
Celtic Pharma Development Services
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP