NCT01369121

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2.3 years

First QC Date

June 7, 2011

Last Update Submit

July 29, 2013

Conditions

Brain EdemaBrain Tumor

Keywords

peritumoral brain edemaedemamalignant brain tumorbrain tumordexamethasoneDecadron

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    To define the maximum tolerated dose (MTD) of Xerecept® in pediatric patients; the MTD will be defined as the dose at which 1 or fewer of six patients experiences a dose limiting adverse event of any kind.

    2 months

Secondary Outcomes (5)

  • Dexamethasone Dosing

    1 Year

  • Incidence and severity of specified Steroid-Related Side Effects

    1 year

  • Number of patients with adverse events

    1 Year

  • Change from baseline in clinical chemistry, hematology and urinalysis measures

    1 Year

  • PedsQL™ Quality of Life Inventory Scores

    1 Year

Study Arms (1)

Xerecept

EXPERIMENTAL

All patients will receive hCRF (XERECEPT)

Drug: XERECEPT

Interventions

XERECEPTDRUG

BID dosing, subcutaneous for 1 year

Also known as: hCRF, Corticorelin acetate injection
Xerecept

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Memorial Hospital, Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60614, United States

Location

Dana-Farber Cancer Institute Pediatric Oncology

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Brain EdemaBrain NeoplasmsEdema

Interventions

Corticotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Stewart Goldman, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 8, 2011

Study Start

June 1, 2010

Primary Completion

October 1, 2012

Study Completion

March 1, 2013

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

US(2)