Study of drug combination therapy for high-risk medulloblastoma in patients over 3 years of age: carboplatin, cisplatin, cyclophosphamide, lomustine, temozolomide, thiotepa, vincristine
This clinical trial focuses on treating high-risk medulloblastoma, which is a type of brain tumor. The study specifically targets patients who have either sonic hedgehog (SHH) subgroup or non-SHH/non-WNT (Groups 3 and 4) medulloblastoma with additional high-risk features. The treatment involves multiple medications including carboplatin, cisplatin, cyclophosphamide, lomustine, temozolomide, thiotepa, and vincristine sulfate.
The purpose of this study is to determine if treatment outcomes can be improved by using either specialized radiation therapy called hyperfractionated-accelerated radiotherapy or high-dose therapy with thiotepa, compared to standard radiation therapy. The study will also evaluate the effectiveness of different maintenance chemotherapy treatments.
The treatment plan combines various methods of drug administration, with some medications given through a vein (intravenous route) and others taken by mouth (oral route). The medications will be given according to specific schedules and doses determined by the study protocol. The study will track how well patients respond to treatment by measuring how long they remain free of disease progression and their overall survival.
1Initial treatment phase
The treatment begins with induction chemotherapy, which includes carboplatin administered through an intravenous line
During this phase, regular blood tests will monitor your blood cell counts and organ function
2Radiation therapy options
You will receive one of two types of radiation therapy:
Option 1: Conventional radiation therapy – once daily treatments
Option 2: Hyperfractionated-accelerated radiation therapy (HART) – multiple treatments per day
3Medication administration
You will receive various medications through different methods:
Intravenous medications: carboplatin, cisplatin, cyclophosphamide, vincristine sulfate, and thiotepa
Oral medications: temozolomide and lomustine in capsule form
The specific schedule and doses will be provided by your medical team
4High-dose therapy phase
Some patients will receive high-dose therapy with thiotepa
This treatment is given through an intravenous line
This phase is followed by conventional radiation therapy
5Maintenance therapy
The final phase includes maintenance chemotherapy
Two different maintenance therapy options are available
Regular monitoring of your health status will continue throughout this phase
6Ongoing monitoring
Regular assessments will track your response to treatment
Blood tests and imaging studies will be performed at scheduled intervals
Your hearing will be monitored throughout the treatment
Who Can Join the Study?
Age at diagnosis must be 3 years or older
Must have confirmed high-risk medulloblastoma (a type of brain tumor) that has been reviewed by specialists
Must be medically fit to receive treatment
Must have adequate:
Liver function (shown by specific blood test results)
Kidney function (shown by normal creatinine levels)
Blood cell counts (specifically neutrophils and platelets at required levels)
Must have good hearing in at least one ear
Must not have received any previous treatment for medulloblastoma except:
Surgery
One course of initial chemotherapy (if urgently needed)
Must provide biological samples including:
Tumor tissue samples
Blood samples
Must provide written informed consent (from patient and/or parent/legal guardian)
For women who can become pregnant:
Must have a negative pregnancy test
Must agree to use effective contraception during treatment
Who Cannot Join the Study?
Prior cancer treatment (chemotherapy, radiotherapy, or immunotherapy) before enrolling in this study, except for surgery to remove the tumor
History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Severe heart problems or unstable heart disease
Severe kidney or liver problems that could affect treatment
Thiotepa is a chemotherapy medication used in high-dose therapy for treating medulloblastoma, a type of brain tumor. It works by interfering with cancer cell DNA, helping to stop tumor growth.
Radiotherapy is a treatment that uses high-energy radiation beams to target and destroy cancer cells. The trial compares two different approaches to radiation therapy:
– Conventional radiotherapy, which delivers radiation once per day
– Hyperfractionated-accelerated radiotherapy (HART), which delivers radiation multiple times per day in smaller doses
The trial also includes maintenance chemotherapy, which is long-term treatment given after the main treatment to help prevent the cancer from returning. Two different maintenance chemotherapy approaches are being compared in this study.
Medulloblastoma – A rare type of brain tumor that starts in the lower back part of the brain called the cerebellum. It begins when brain cells have changes in their DNA, causing cells to grow and divide uncontrollably. The disease can occur in different subtypes, including sonic hedgehog (SHH) and Groups 3 and 4 variants. Medulloblastoma tends to spread through the cerebrospinal fluid that surrounds and protects the brain and spinal cord. The condition can affect both children and adults, though it’s more commonly found in children.
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