Tolerability Study of Xerecept® in Pediatric Patients

Stopped early · Phase 1/Phase 2

Conditions studied: Brain Edema, Brain Tumor

In brief

This study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials.

Key facts

Study ID

NCT01369121

Run by

Celtic Pharma Development Services

People needed

15

Starts

2010-06-01

Expected to finish

2013-03-01

Last updated by the study team

2013-07-30

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have histologically confirmed primary, recurrent or metastatic cerebral tumors and require chronic steroid dosing to manage symptoms of peritumoral brain edema (No histological confirmation is required of optic pathway tumors or brain stem gliomas)
• Have been taking dexamethasone (or equivalent) at a dose of ≥1 mg/day for a minimum of 14 days and have had a stable dose for at least 7 days.
• Have one or more steroid-associated side effects at Screening (See Appendix A1 for a list of qualifying events)
• Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
• Karnofsky/Lansky performance status ≥ 40
• Life expectancy of at least 6 months
• Female subjects must not be pregnant or breast-feeding and, if of childbearing potential, must use adequate methods of contraception during the study
• Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed

You may not qualify if…

• Evidence of previous or current overt renal, hepatic or pulmonary diseases or active uncontrolled infection
• Subject and/or parent/guardian is unwilling or unable to comply with this protocol
• Subject has a known history of allergy or intolerance to hCRF or other ingredients in the Xerecept® solution (e.g., methionine, mannitol)
• Subject has a known history of hepatitis C virus, hepatitis B surface, or human immunodeficiency virus (HIV).

Where it is running

• Children's Memorial Hospital, Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Dana-Farber Cancer Institute Pediatric Oncology — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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