Tolerability Study of Xerecept® in Pediatric Patients
Information source: Celtic Pharma Development Services
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Edema; Brain Tumor
Intervention: XERECEPT (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Celtic Pharma Development Services Official(s) and/or principal investigator(s): Stewart Goldman, MD, Principal Investigator, Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
Summary
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.
Clinical Details
Official title: A Phase I/II Open Label Individual Dose Titration Trial of the Human Corticotropin- Releasing Factor (hCRF), Corticorelin Acetate Injection (Xerecept®), to Determine the Tolerability of Xerecept® in a Pediatric Population
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum Tolerated Dose
Secondary outcome: Dexamethasone DosingIncidence and severity of specified Steroid-Related Side Effects Number of patients with adverse events Change from baseline in clinical chemistry, hematology and urinalysis measures PedsQLâ„¢ Quality of Life Inventory Scores
Detailed description:
Steroid-related side effects are much more severe in a pediatric population than they are in
adults. The side effects appear more quickly and are often apparent in as few as 14 days.
Dexamethasone side effects in children include rounding of the face, acne, increased body
hair, muscle weakness, osteoporosis, mood changes, weight gain, fluid retention, glucose
instability, high blood pressure, increased susceptibility to infection, stunted growth and
aseptic necrosis of the hip joints14-16.
Although extensive studies have been performed with Xerecept® in adults, no studies have
been performed with Xerecept® in pediatric subjects. Therefore, 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. The study will also explore if Xerecept®, when
administered to pediatric patients, is effective in allowing decreases in dexamethasone
dosing
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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)
2. 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.
3. Have one or more steroid-associated side effects at Screening (See Appendix A1 for a
list of qualifying events)
4. Capable of self-administration of subcutaneous injections twice daily or availability
of assistance from caregiver.
5. Karnofsky/Lansky performance status ≥ 40
6. Life expectancy of at least 6 months
7. Female subjects must not be pregnant or breast-feeding and, if of childbearing
potential, must use adequate methods of contraception during the study
10. Ability to provide written informed consent or, if unable to provide, have a legal
guardian or representative provide written informed
Exclusion Criteria:
1. Evidence of previous or current overt renal, hepatic or pulmonary diseases or active
uncontrolled infection
2. Subject and/or parent/guardian is unwilling or unable to comply with this protocol
3. Subject has a known history of allergy or intolerance to hCRF or other ingredients in
the Xerecept® solution (e. g., methionine, mannitol)
4. Subject has a known history of hepatitis C virus, hepatitis B surface, or human
immunodeficiency virus (HIV).
Locations and Contacts
Children's Memorial Hospital, Northwestern University Feinberg School of Medicine, Chicago, Illinois 60614, United States
Dana-Farber Cancer Institute Pediatric Oncology, Boston, Massachusetts 02115, United States
Additional Information
Starting date: June 2010
Last updated: July 29, 2013
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