Reduced Radiation + Chemotherapy for Medulloblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients with seizure disorders can participate if their condition is well controlled with anticonvulsants. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment for medulloblastoma?
Research shows that chemotherapy, including drugs like vincristine and cisplatin, is increasingly effective for treating medulloblastoma, especially when combined with radiation therapy. Studies suggest that adding chemotherapy to reduced-dose radiotherapy may improve survival rates and reduce the need for higher doses of radiation.12345
Is the treatment of reduced radiation and chemotherapy for medulloblastoma generally safe in humans?
The treatment involving reduced radiation and chemotherapy for medulloblastoma has shown some safety concerns, including short-term toxicity and potential hearing loss (ototoxicity) due to radiation and certain chemotherapy drugs like cisplatin. However, substituting cisplatin with carboplatin may reduce the risk of hearing loss, although other side effects like hematologic toxicity (blood-related side effects) can still occur.36789
How does the treatment of reduced radiation and chemotherapy for medulloblastoma differ from other treatments?
This treatment is unique because it combines reduced-dose radiation with chemotherapy to potentially improve survival rates while minimizing the harmful side effects of full-dose radiation, especially in children. The approach aims to balance effective cancer treatment with reducing long-term damage, which is particularly important for young patients.3451011
What is the purpose of this trial?
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.
Research Team
Nicholas J Gottardo
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for young patients with a newly diagnosed brain tumor called WNT-driven medulloblastoma. Eligible participants must be between 3 and 22 years old, have good kidney and liver function, adequate blood counts, no prior tumor-directed therapy except surgery/corticosteroids, not pregnant or breastfeeding, agree to use contraception if applicable, and able to perform required language skills for assessments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation Therapy
Patients undergo craniospinal radiation therapy 5 days a week for 6 weeks
Maintenance Therapy (Weeks 1, 3, 5, and 7)
Patients receive lomustine orally on day 1, vincristine sulfate intravenously on days 1, 8, and 15, and cisplatin intravenously on day 1. Treatment repeats every 42 days.
Maintenance Therapy (Weeks 2, 4, and 6)
Patients receive cyclophosphamide and mesna intravenously on days 1 and 2, and vincristine sulfate intravenously on days 1 and 8. Treatment repeats every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cisplatin
- Cyclophosphamide
- Lomustine
- Radiation Therapy
- Vincristine
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator