Chemotherapy + Radiation for Medulloblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different combinations of chemotherapy and radiation therapy to determine the most effective treatment for high-risk medulloblastoma in young patients. The chemotherapy drugs—vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin—aim to stop tumor growth by killing the cells or preventing them from dividing. The trial seeks patients newly diagnosed with medulloblastoma who have not yet received any treatment. Participants should have a specific tumor profile, identifiable through MRI scans, before joining the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but it advises avoiding certain drugs that interact with the trial medications. Specifically, drugs that strongly affect liver enzymes (like some antifungals and seizure medications) should be avoided with vincristine, and caution is advised with other medications when taking cisplatin. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments in this trial have established safety records from past studies. Carboplatin, used with radiation therapy, often causes side effects such as low white blood cell and platelet counts, which are common with chemotherapy drugs.
Cisplatin, a standard treatment for medulloblastoma, can lead to hearing loss and kidney issues. Despite these side effects, it has been used for a long time due to its effectiveness in treating these tumors.
Cyclophosphamide may cause serious side effects, especially in children who have previously undergone radiation therapy. These effects can impact the bone marrow and other body systems.
Vincristine sulfate, another drug in the trial, is widely used for various cancers and is known for side effects like nerve damage and low blood counts.
Radiation therapy, an important part of this trial, is well-known for treating medulloblastoma and can cause side effects such as tiredness and skin changes.
These treatments are in a late-stage trial, indicating they have shown some safety in earlier studies. Discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for medulloblastoma because they combine chemotherapy and radiation in innovative ways to enhance effectiveness. Unlike most standard treatments that utilize these therapies separately, this approach integrates carboplatin or isotretinoin with radiation and traditional chemotherapy agents like cisplatin and vincristine sulfate. This combination aims to improve the overall impact on the tumor. Additionally, the use of isotretinoin in continuation therapy is a unique feature, as it may help prevent disease recurrence and manage toxicity better than current options. Overall, this multi-faceted strategy could offer a more powerful and comprehensive attack on cancer cells, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for medulloblastoma?
This trial will evaluate different combinations of treatments for medulloblastoma. Studies have shown that adding carboplatin to radiation therapy, as in Arm B, can improve survival rates for children with high-risk group 3 medulloblastoma from 54% to 73%. Research indicates that chemotherapy with cisplatin, used in Arm A, has increased survival rates in children with medulloblastoma over the past decade. Cyclophosphamide, included in the maintenance therapy for Arm A, is commonly used for this condition, though its exact effect on brain tumors remains unclear. Vincristine, another chemotherapy drug used across the arms, has improved cure rates for medulloblastoma from 40% to 70% over time. Radiation therapy, especially using protons, effectively controls the disease and offers better long-term outcomes for brain function. Together, these treatments provide a comprehensive approach with proven benefits in treating high-risk medulloblastoma in children.16789
Who Is on the Research Team?
Sarah E Leary
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for young patients with a high-risk type of brain tumor called medulloblastoma, who haven't been treated before. They should have normal liver and kidney function, no history of certain drug use that affects the liver enzyme CYP450 3A4, and acceptable blood counts. Pregnant or breastfeeding women can't join, and participants must agree to use birth control. Patients need to be able to perform daily activities at least minimally despite their illness.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiotherapy
Patients undergo radiation therapy and receive vincristine sulfate, with carboplatin for some arms, for 6 weeks
Maintenance Therapy
Patients receive cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim, repeating every 28 days for 6 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Cyclophosphamide
- Radiation Therapy
- Vincristine Sulfate
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?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator