Risk-Directed Therapy for Medulloblastoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires that any chemotherapy, immunotherapy, or targeted agents for non-cancer conditions be stopped at least 14 days before starting the trial treatment. Corticosteroid therapy is allowed.
What data supports the effectiveness of the drugs used in the Risk-Directed Therapy for Medulloblastoma?
The research articles provided focus on managing chemotherapy-induced nausea and vomiting (CINV) in patients receiving treatments like cisplatin and carboplatin, which are part of the medulloblastoma therapy. These studies suggest that antiemetic combinations, such as ondansetron with dexamethasone, are effective in reducing CINV, which can improve the overall treatment experience for patients undergoing similar chemotherapy regimens.12345
Is the treatment for medulloblastoma generally safe in humans?
What makes the Risk-Directed Therapy for Medulloblastoma treatment unique?
This treatment is unique because it combines multiple chemotherapy drugs, radiation, and surgery to target medulloblastoma, a type of brain cancer, based on the patient's specific risk factors. This personalized approach aims to maximize effectiveness while minimizing side effects, unlike standard treatments that may not be tailored to individual risk levels.2451112
What is the purpose of this trial?
This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.
Research Team
Giles Robinson, MD
Principal Investigator
St. Jude Children's Research Hospital
Aditi Bagchi
Principal Investigator
St. Jude Children's Research Hospital
Eligibility Criteria
This trial is for children under 5 years with newly diagnosed medulloblastoma. They must have a certain level of organ function, no prior brain tumor treatments except surgery, and a performance score over 30. Parents can consent and participate in educational interventions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Surgical resection of the tumor prior to chemotherapy
Chemotherapy
Participants receive systemic high-dose methotrexate (HD-MTX) and conventional chemotherapy, with variations based on stratum assignment
Radiation
Risk-stratified craniospinal irradiation (CSI) for Stratum N participants at 36 months of age
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Cisplatin
- Cyclophosphamide
- Etoposide
- Filgrastim
- Irradiation
- Methotrexate
- Ommaya/VPS
- Pegfilgrastim
- Surgical resection
- Topotecan
- Vincristine
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
National Cancer Institute (NCI)
Collaborator