A study to evaluate the role of modified regular interval based combined oral chemotherapy that regresses tumor cell development of various forms which is indicated for the treatment of High-Risk Medulloblastoma (a type of brain tumor)
- Conditions
- Health Condition 1: C716- Malignant neoplasm of cerebellum
- Registration Number
- CTRI/2019/09/021213
- Lead Sponsor
- TMC Research Administration Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
High risk medulloblastoma as defined by
anaplastic or large cell variant histology
Molecular High risk subgroups (Group 3 or 4 disease) defined by presence of MYC
amplification/MYC overexpression or CDK6 amplification
-Leptomeningeal disease as evidenced on MRI of brain and spine at the time of diagnosis
Cerebrospinal fluid cytology positivity for malignancy
Metastatic disease involving the neuraxis
Children should have achieved a CR or PR with standardtherapy defined as
CR â?? complete clearing of radiographic disease for at least 4 weeks
PR â?? >50% decrease in the sum of the products of all two dimensional masses for a minimum
of 4 weeks
[4] Children must have normal organ and marrow function as defined below:
• Leukocyte count >3,000/mcL
• ANC >1,500/mcL
• Platelets >100,000/mcL
• Total bilirubin <2.0mg/dL
• AST/ALT <3 times upper limit of normal
• Creatinine clearance >60 mL/min/1.73 m2 as calculated by Shwartz estimate
1] Children stratified as high risk purely by extent of residual disease post surgery
[2] Relapsed or refractory medulloblastoma
[3] History of allergic reactions attributed to compounds of similar chemical or biologic
composition as that of the agents used in the study.
[4] Parents unwilling to wait till therapy completion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine improvement in Event Free SurvivalTimepoint: On monthly follow-up visit till one year and followed by 3 monthly follow-up visit for further 2 years.
- Secondary Outcome Measures
Name Time Method To determine the <br/ ><br>[1] Improvement in OS <br/ ><br>[2] Toxicity and safety (CTCAE v4.03)Timepoint: During Treatment/Follow up