Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: CCNU regimen plus Mebendazole: 1. Tablet pantoprazole 40 mg- Early morning empty stomach.
2. Mebendazole tablets would be chewed with breakfast (800 mg)- Breakfast for the entire cycle
Sponsors
Cancer Research and Statistics Foundation CRSF
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have relapsed glioma (Clinico-radiological or pathological confirmation) 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 3. Subjects must have normal organ and marrow function as per institute protocols 4. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have an absence of active AIDS-defining conditions. 5. Both men and women of all races and ethnic groups are eligible for this study. 6. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals, and/or nature of required assessments. 7. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Subjects who are receiving any other investigational agents. 2. Within 2 weeks of administration of a chemotherapeutic agent. 3. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active)cardiovascular disease: cerebrovascular accident/stroke ( Association Classification Class II), or serious cardiac arrhythmia requiring medication. 4. Patients with severe renal and liver dysfunction 5. Active infection requiring systemic therapy. 6. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions (NCI-CTCAE v5 Grade = 3). 7. Pregnant and lactating women are excluded from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the overall survival (OS) between the two arms.Timepoint: OS will be calculated in time in months between the date of randomization to the date of death. Patients alive at their last follow ups will also be censored. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the Progression-free survival, adverse events, and the quality of life between the two arms.Timepoint: 1. PFS will be calculated in time in months from the date of randomization to the date of progression/death whichever is earlier. Participants who have not progressed till their last follow-ups will also be censored. 2. Adverse events will be noted through the treatment. 3. Quality of life questionnaires will be collected at baseline, 1.5 months, 3 months, and 6 months. | — |
Countries
India
Contacts
Public ContactDr Vijay Patil
Tata Memorial Centre
Outcome results
None listed