Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Mycophenolate Mofetil 500 mg twice daily: In operated cases of high grade gliomas, mycophenolate mofetil(MMF) is added to standard of care adjuvant chemoradiotherapy and adjuvant chemot
Sponsors
All India Institute Of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Histologically proven cases of Gliobastoma, Astrocytoma and unspecified high grade gliomas of grades 3 and and 4 Karnofsky Performance score more than 50 Normal hematological, renal and hepatic functioning Written Consent
Exclusion criteria
Exclusion criteria: Age less than 18 years Pregnant and lactating females Documented allergic reactions to mycophenolate mofetil Patients already on mycophenolate mofetil for immunological disorders Low grade gliomas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if the currently recommended phase 2 dose of mycophenolate mofetil is suitable for Indian patients with high grade gliomasTimepoint: 6 weeks : at the completion of concurrent chemoradiation and 6 months : after starting adjuvant temozolomide | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the Objective response rate(ORR)as per RANO criteriaTimepoint: At 8 weeks of completion of chemoradiotherapy and 12 weeks after completion of adjuvant temozolomide;To evaluate the Progression free survival at 6 months(PFS6)Timepoint: 6 months after diagnosis of high grade glioma;To evaluate the Overall survival(OS)Timepoint: 2 years from the time of diagnosis;To evaluate the impact of adding mycophenolate mofetil to standard therapy in terms Quality of life and toxicities developedTimepoint: upto 1 year | — |
Countries
India
Contacts
Public ContactDr Kalyani A Nair
ll India Insititute of Medical Sciences,(AIIMS), Jodhpur
Outcome results
None listed