Health Condition 1: C716- Malignant neoplasm of cerebellum
Conditions
Interventions
Intervention1: Lomustine (CCNU): Dose/Schedule: 110 mg/m2 PO once on Day 1 of each 6 week cycle
round to nearest capsule strength per institutional pharmacy
maximum absolute dose 160 mg.
Intervention2: Cetuximab: Dose/Schedule: 500 mg/m2 IV every 2 weeks (Days 1, 15, 29 of each 6 week cycle)
infuse
over 120 minutes
complete infusion more than equal to 1 hour prior to CCNU on Day 1.
Control Intervention1: NIL: NA
Sponsors
SunAct Cancer Institute Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age more than equal to18 years and histologically confirmed WHO grade 4 Glioblastoma or Gliosarcoma. 2.Radiographic first or second recurrence after prior standard radiotherapy with concurrent or adjuvant temozolomide. 3.Measurable enhancing disease by MRI per RANO within 14 days prior to randomization and stable or decreasing corticosteroid dose for more than equal to 5 days before baseline MRI. 4.ECOG performance status 0 to 2. 5.Adequate organ function ANC more than equal to 1.5 109 per L platelets more than equal to 100 109 per L hemoglobin more than equal to 9 g per dL total bilirubin less than equal to 1.5 ULN AST or ALT less than equal to 2.5 ULN creatinine clearance more than equal to 50 mL per min (Cockcroft Gault). 6.Life expectancy more than equal to 12 weeks. 7.MGMT promoter methylation and EGFR status (amplification or EGFR vIII) locally assessed if available 8.Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during treatment and for 6 months after last dose. 9.Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during treatment and for 6 months after last dose and men must agree to use contraception. 10.Written informed consent obtained prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1.More than two prior systemic anticancer regimens for GBM at recurrence. 2.Prior EGFR targeted therapy for GBM e.g., cetuximab, panitumumab, EGFR TKIs at recurrence. 3.Known IDH mutant astrocytoma grade 4 without histologic features of GBM (central confirmation not required). 4.Uncontrolled intercurrent illness including active infection requiring systemic therapy significant pulmonary disease predisposing to infusion reactions; uncontrolled cardiac disease (NYHA class III/IV). 5.Known severe hypersensitivity to cetuximab, murine proteins, or components of the formulation history of severe infusion reaction to chimeric antibodies. 6.Pregnancy or breastfeeding. 7.Inability to undergo MRI with contrast or to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the 6 months progression free survival rate for patients treated with cetuximab and CCNUTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate progression-free survival (PFS) and overall survival (OS). 2. Estimate objective response rate (ORR) and duration of response (DoR) per RANO. Assess safety and tolerability per NCI CTCAE v5.0; characterize infusion reactions and electrolyte disturbances associated with cetuximab; characterize myelosuppression with CCNU. 3. Evaluate corticosteroid-sparing effect (change in daily dexamethasone equivalent). Assess health-related quality of life (EORTC QLQ C30 and QLQ BN20) and neurologic function (MMSE or MoCA).Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Sayalee Jadhav
SunAct Cancer Institute Pvt Ltd
Outcome results
None listed