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Brain EdemaPhase 3NCT00088166

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

A Phase 3 study testing hCRF in people with Brain Edema and Brain Tumor, run by Celtic Pharma Development Services at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Edema, Brain Tumor
What is being tested?
hCRF
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
34 sitesin 2 countries
Study dates
May 2004to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States27 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Northwestern University, Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University Hematology Oncology Care, LLC

    Cincinnati, Ohio, 43210

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • The Ohio State University

    Columbus, Ohio, 43210

  • Hermelin Brain Tumor Center, Henry Ford Hospital

    Detroit, Michigan, 48202

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Evanston Northwestern Healthcare

    Evanston, Illinois, 60201

  • UCSF Fresno Center for Clinical Studies

    Fresno, California, 93702

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3596

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Cancer Institute of Orlando

    Orlando, Florida, 32804

  • Stanford University Medical Center

    Palo Alto, California, 94305

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Oregon Clinic

    Portland, Oregon, 97210

  • Neurology Group of Bergen County

    Ridgewood, New Jersey, 07450

  • UC Davis Medical Center, Division of Medical Oncology

    Sacramento, California, 95817

  • UC San Diego, Thornton Hospital

    San Diego, California, 92037

  • Virginia Mason Clinic

    Seattle, Washington, 98111

  • Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612-9497

Other trials in United States

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G1ZT

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Sunnybrook and Women's College Health

    Toronto, Ontario, M4N 3M5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
hCRF, placebo hCRF
Keywords
peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
Medical subject headings
Brain Edema, Brain Neoplasms, Edema, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hCRFDrug

    Also called XERECEPT (corticorelin acetate injection); hCRF

    hCRF ; open-label dexamethasone that the patient is currently taking

  • placebo hCRFDrug

    Also called XERECEPT (corticorelin acetate injection)

    placebo hCRF 2mg/day and open-label dexamethasone that they are taking

Study groups in NCT00088166
Study groupRoleWhat they receive
IExperimentalPatients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
Receives: Drug: hCRF
IIPlacebo comparatorPatient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
Receives: Drug: placebo hCRF

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: Prospective

Secondary outcomes (8)

  1. 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

    Measured: Prospective

  2. 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

    • The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.

    Measured: Prospective

  3. Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)

    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). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.

    Measured: Prospective

  4. Change From Baseline in the Karnofsky Performance Score

    Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:

    100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.

    50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.

    20 - Very sick; hospital admission necessary; active supportive treatment nec

    Measured: Prospective

  5. Change From Baseline in the FACT-Br Quality of Life Results

    The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)

    Measured: Prospective

  6. Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)

    Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).

    Measured: Prospective

  7. Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study

    The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.

    Measured: Prospective

  8. Number of Patients Who Discontinued Study Drug Prior to the End of Week 5

    Numbers of patients who discontinued prior to the Week 5 assessment

    Measured: Prospective

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00088166
Sponsor's protocol ID
NTI 0303
Other IDs
XERECEPT®
Status last verified
Jul 2014
First submitted
20 Jul 2004
Last updated
13 Aug 2014
Data monitoring committee
Yes

Publications

  • Recht L, Mechtler LL, Wong ET, O'Connor PC, Rodda BE. Steroid-sparing effect of corticorelin acetate in peritumoral cerebral edema is associated with improvement in steroid-induced myopathy. J Clin Oncol. 2013 Mar 20;31(9):1182-7. doi: 10.1200/JCO.2012.43.9455. Epub 2013 Feb 4.

    PubMed 23382470

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hCRF in people with Brain Edema and Brain Tumor, run by Celtic Pharma Development Services at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00088166, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.

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