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)

A Phase 2 Randomized Controlled Trial To Evaluate The Role Of Modified C.O.M.B.A.T Maintenance Regimen in Children With High Risk Medulloblastoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021213

Enrollment

128

Registered

2019-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C716- Malignant neoplasm of cerebellum

Interventions

Intervention1: C.O.M.B.A.T: Combined Oral Metronomic Bio-differentiating Antiangiogenic Treatment Comprising Of Following Drug Regimen: Agent A: Temozolamide 60mg/m2/day from week 0 to week 6, to be g

Eligibility

Inclusion criteria

Inclusion criteria: 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 • AST/ALT • Creatinine clearance >60 mL/min/1.73 m2 as calculated by Shwartz estimate

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To determine the [1] Improvement in OS [2] Toxicity and safety (CTCAE v4.03)Timepoint: During Treatment/Follow up	—

Countries

India

Contacts

Public ContactDr Girish Chinnaswamy

Tata Memorial Hospital

girish.c.tmh@gmail.com912224176764

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026