Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, San Francisco
Study ID
NCT05057702
Status
Recruiting
Apply to this trial

Conditions

  • Ependymoma
  • Ependymoma Malignant
  • Ependymoma of Brain
  • Medulloblastoma
  • Medulloblastoma Recurrent
  • Medulloblastoma, Childhood

Eligibility Criteria

Sex
ALL
Age
12 Months - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Specialized Tumor Board Treatment Plan — OTHER
    Specialized Treatment Plan of up to four FDA approved drugs based on participant's screening results will be assigned by PNOC specialized tumor board
  • Combinations — OTHER
    Specialized Treatment Plan of up to four FDA approved drugs based on participant's screening results will be assigned by PNOC specialized tumor board

Study Details

The current study will use a new treatment approach based on the molecular characteristics of each participant's tumor. The study will test the feasibility in the pilot phase of performing real-time drug screening on tissue taken during surgery in patients with relapsed medulloblastoma or ependymoma and of having a specialized tumor board assign a treatment plan based on the results of this screening and genomic sequencing. The aim of this trial is to allow every child and young adult with relapsed medulloblastoma and ependymoma to receive the most effective and least toxic therapies currently available and will pave the way for improved understanding and treatment of these tumors in the future. Moreover, if successful, it could serve as a paradigm for personalized medicine programs for other types of cancer.

Key Dates

Start date
Feb 22, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Individualized Treatment Recommendation (Pilot Phase)
    Participants will receive an individualized treatment recommendation including a combination of up to four FDA-approved drugs within 21 business days of tissue acquisition using the results of real-time high-throughput drug screening, whole exome sequencing (WES), and RNA sequencing.
  • Experimental: Individualized Treatment Recommendation (Efficacy Phase)
    Participants will receive an individualized treatment recommendation including a combination of up to four FDA-approved drugs within 21 business days of tissue acquisition using the results of real-time high-throughput drug screening, whole exome sequencing (WES), and RNA sequencing.

Primary Outcome Measure

Number of participants for whom treatment recommendations are fully completed within 21 business days of tissue collection based on drug screening (Pilot Phase) [ Time Frame: Up to 21 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Ashley Margol, MD
[email protected]
323-361-8147
Tom Davidson, MD
[email protected]
Ashley Margol, MD (PRINCIPAL_INVESTIGATOR)
Tom Belle Davidson, MD (SUB_INVESTIGATOR)
Rady Children's HospitalSan DiegoCalifornia92123
Jennifer Elster, MD
[email protected]
858-576-1600
Megan Paul, MD
[email protected]
Jennifer Elster, MD (PRINCIPAL_INVESTIGATOR)
Megan Paul, MD (SUB_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
PNOC Operations Office
[email protected]
415-502-1600
Sabine Mueller, MD, PhD (PRINCIPAL_INVESTIGATOR)
Alyssa Reddy, MD (SUB_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Lindsay Kilburn, MD
[email protected]
202-476-3854
Roger Packer, MD
[email protected]
202-476-5973
Lindsay Kilburn, MD (PRINCIPAL_INVESTIGATOR)
Roger Packer, MD (SUB_INVESTIGATOR)
St. Louis Children's Hospital / Washington University in St. LouisSt LouisMissouri63130
Mohamed Abdelbaki, MD
[email protected]
314-454-6018
Andrew Cluster, MD
[email protected]
Mohamed Abdelbaki, MD (PRINCIPAL_INVESTIGATOR)
Andrew Cluster, MD (SUB_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
James H Garvin Jr., MD
[email protected]
212-305-9770
James H Garvin Jr., MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Jessica Clymer, MD
[email protected]
212-263-9949
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Cassie Kline, MD, MAS
[email protected]
267-426-9359
Jane Minturn, MD, PhD
[email protected]
267-426-5026
Cassie Kline, MD, MAS (PRINCIPAL_INVESTIGATOR)
Jane Minturn, MD, PhD (SUB_INVESTIGATOR)

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