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Title
Status

 

PBTC-058 - Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients With Recurrent Medulloblastoma and Ependymoma

Open

PBTC-058 - Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients With Recurrent Medulloblastoma and Ependymoma

Go to Health Care Provider version

DiagnosisRecurrent Medulloblastoma Recurrent EpendymomaStudy StatusOpen
PhaseII
Ageup to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Irinotecan (IV) Drug: Temozolomide (Oral) Drug: Bevacizumab (IV) Drug: Omburtamab I-131 (via Intraventricular Access Device (i.e., Ommaya catheter or programmable VP shunt)) Pre-medication: Drug: Liothyronine (Orally, NG, or G-tube) Drug: SSKI (Orally, NG, or G-tube) Drug: Dexamethasone (Oral) Drug: Antipyretic (Oral acetaminophen [15 mg/kg, 650 mg maximum] or equivalent) Drug: Antihistamine (IV diphenhydramine [1 mg/kg, 50 mg maximum] or equivalent) Drug: Anti-emetics (IV ondansetron [0.25 mg/kg, 16 mg maximum] or equivalent)
Last Posted Update2024-02-09
ClinicalTrials.gov #NCT04743661
International Sponsor
Sponsor:
Pediatric Brain Tumor Consortium

Collaborators:
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics, Inc
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

For patients who have medulloblastoma or ependymoma, there is a clear need to develop more effective therapies. This research will study an investigational drug called 131I-omburtamab, which is given in an intraventricular access device (i.e., Ommaya or programmable VP shunt), to see if it is safe for children when added to standard chemotherapy (anti-cancer therapy). The research will also investigate whether the addition of 131I-Omburtamab lowers the chance of tumor growth and improves survival compared to patients in the past who only received chemotherapy and/or radiation therapy.

(via: PBTC-058 Patient and Family Summary_v2_05-28-2021.pdf)

Inclusion Criteria

Inclusion Criteria Group 1:

  • Patients must have a confirmed diagnosis of medulloblastoma that has come back, progressed or not responded to other standard treatment
  • Patients must be 21 years old or younger to participate 
  • Patients must be willing to undergo a surgical procedure to place an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal [VP] shunt or Ommaya reservoir) if they do not have one already
  • Patients must be able to be up and about for over half of their waking hours
  • Organ function and blood work requirements must be met
  • Patients must not be pregnant or get pregnant during the course of this study or for at least 6 months after. If patients are of childbearing or child fathering potential, they must be willing to use a medically acceptable form of birth control, including abstinence. 
  • Patients receiving corticosteroids at a stable or decreasing dose for at least 7 days prior to enrollment are eligible
  • Patients must be willing to agree with study visit requirements and be able to understand and sign a written informed consent document 

Inclusion Criteria Group 2: 

  • Patients must have a confirmed diagnosis of ependymoma that has come back, progressed or not responded to other standard treatment
  • Patients must have evidence of tumor reactivity for B7H3 (CD276), if prior testing is not available, patient samples must be sent to Memorial Sloan Kettering Cancer Center to be tested
  • Patients must be 21 years old or younger to participate
  • Patients must be willing to agree with study visit requirements and be able to understand and sign a written informed consent document 
  • Patients screened for this trial should be expected to meet criteria for treatment as outlined in the protocol. 

Other inclusion criteria may apply and will be discussed with you by the study team.