Craniopharyngioma, Child Clinical Trial
Official title:
Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy
Verified date | February 2024 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.
Status | Enrolling by invitation |
Enrollment | 250 |
Est. completion date | December 2030 |
Est. primary completion date | February 2, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Days to 21 Years |
Eligibility | Inclusion Criteria: 1. Patients between 0-21 years of age. 2. Patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling. Exclusion Criteria: 1. Patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma 2. Patients in whom tissue specimen is not obtained/available 3. Patients over 21 years of age. 4. Patients who choose not to participate |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets through mRNA expression. | Beginning of study to end of study, up to 1 year. | |
Primary | Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets through microarray analysis. | Beginning of study to end of study, up to 1 year. | |
Primary | Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets immunohistochemistry. | Beginning of study to end of study, up to 1 year. | |
Primary | Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets through quantitative PCR. | Beginning of study to end of study, up to 1 year. | |
Primary | Identification of Potential Therapeutic Targets | Investigators will also perform immunostaining for beta-catenin and use DNA SNaPshot analysis to determine what parts of the tumor are responsible for observed gene signatures. | Beginning of study to end of study, up to 1 year. | |
Secondary | Survival | The amount of time the patient survives with or without the disease. | Beginning of study up to age 21 or death, whichever comes first. | |
Secondary | Progression Free Survival (PFS) | The amount of time the patient survives without advancement of disease. | Beginning of study up to age 21 or death, whichever comes first. | |
Secondary | Visual Deficit Assessment | With regard to visual deficits, investigators will compare the rates of functional blindness, unilateral blindness, and visual field deficit. | At 6 and 12 months after the specimen sample was taken. | |
Secondary | Pituitary Function Assessment | With regard to pituitary function, investigators will assess patients based on the quality of life impairment that is associated with their dysfunction. Assessment will be divided among 4 groups:
No dependence on hormone supplementation or evidence of diabetes insipidus Dependence on 1 or 2 hormone supplements without diabetes insipidus The presence of diabetes insipidus with or without the need for 2 or fewer hormone supplements Diabetes Insipidus with panhypopituitarism |
At 6 and 12 months after the specimen sample was taken. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05465174 -
Nivolumab and Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults
|
Phase 2 |