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

What Was Tested

The trial (phase 3) is built around CRH (Corticotropin-Releasing Hormone).

It had two arms (groups): I (experimental) and II (placebo comparator).

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

The registry classes the interventions as drug.

Who Took Part

200 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. 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.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the CRH (Corticotropin-Releasing Hormone) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received CRH (Corticotropin-Releasing Hormone).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2004-05 with completion listed for 2008-03.

It ran at 34 sites in United States (27) and Canada (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 also tracked 8 secondary outcomes, for example 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, 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 Karnofsky Performance Score, Change From Baseline in the FACT-Br Quality of Life Results and Number of Patients Who Discontinued Study Drug Prior to the End of Week 5.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of CRH (Corticotropin-Releasing Hormone) in 200 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the CRH (Corticotropin-Releasing Hormone) compound page, all human trials.