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XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

C

Celtic Pharma Development Services

Status and phase

Withdrawn
Phase 3

Conditions

Brain Edema
Brain Tumor

Treatments

Drug: placebo hCRF
Drug: hCRF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00226668
corticorelin acetate injection
NTI 0302

Details and patient eligibility

About

The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

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

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed diagnosis of a primary malignant glioma.
  • Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
  • If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
  • Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
  • Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.

Exclusion criteria

  • Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
  • Systemic steroid use for any other indication than peritumoral brain edema.
  • Patients on dexamethasone or anticonvulsant therapy.
  • Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
  • Central nervous system (CNS) infection.
  • Conditions that are considered contradictions for patients to receive niacin

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups, including a placebo group

I
Experimental group
Description:
Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
Treatment:
Drug: hCRF
II
Placebo Comparator group
Description:
Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
Treatment:
Drug: placebo hCRF

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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