Health Condition 1: D496- Neoplasm of unspecified behavior of brain
Conditions
Interventions
Intervention1: Lutetium (177Lu) DOTATATE: The intervention consists of a maximum of four sessions of Lutetium-177 (Lu-177) DOTATATE Peptide Receptor Radionuclide Therapy (PRRT), with each session spac
Sponsors
Tata Research and Administrative Council(TRAC)
Eligibility
Inclusion criteria
Inclusion criteria: High risk meningioma is defined as: 1. WHO Grade II meningioma, post gross total resection of the tumour, presenting with recurrent disease and post salvage EBRT showing SSTR expression on Ga68 DOTANOC PET CT done at least 2 weeks prior to PRRT. 2. Grade II meningioma, post subtotal tumour resection and post adjuvant EBRT having residual disease & showing SSTR expression on Ga68 DOTANOC PET/CECT done at least 2 weeks prior to PRRT. 3. Newly diagnosed grade III meningioma: i. Unresectable who have received EBRT and showing positive SSTR expression on DOTANOC PET/CECT done at least 2 weeks prior to PRRT. ii. Post tumour resection and post EBRT, showing residual disease & SSTR expression on DOTANOC PET/CECT done at least 2 weeks prior to PRRT. (Extent of resection will be assigned by operating neurosurgeon using Simpson s grade) 4. Age more than or equal to 18 5. ECOG less than or equal 2 6. Normal haematological function (Hb more than 8, PLT more than 80000, ANC more than 1500) 7. Optimal renal function (RFT) (Calculated Creatinine clearance more than 30 ml/min) Optimal liver function (LFT) (Total bilirubin less than 1.5 institutional upper limit of normal. AST(SGOT)/ALT(SGPT)less than or equal to 2.5 institutional upper limit of normal) (Criteria for Positive Ga68 DOTANOC PET/CT: Uptake at the target tumour sites should be equal to or more than liver)
Exclusion criteria
Exclusion criteria: 1. Participants with recurrent grade III meningioma who have progressed on first line treatment. 2. Participants who are receiving any other investigational agents. 3. Within 3 weeks of administration of any cancer directed therapy. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 5. Uncontrolled intercurrent illness including or psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant women and breastfeeding women. 7. Patient s refusal to give informed consent and participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine 3-year progression free survival in patients with high-risk meningioma receiving Lu 177 DOTATATE PRRT.Timepoint: To determine 3-year progression free survival in patients with high-risk meningioma receiving Lu 177 DOTATATE PRRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine objective tumour response rate using (DOTA PET CT/MRI) at defined intervals.Timepoint: 4 weeks of completion of 2 and 4 sessions of PRRT;To determine the toxicity profile of intravenously administered Lutetium 177 DOTATATE PRRT in high risk grade meningioma patients.Timepoint: At each treatment cycle and weekly during the radiation therapy review.;To assess the quality of life using EORTC & BN20 criteria.Timepoint: At baseline, 6 10 days before each PRRT cycle, 3 months after the last cycle, every 3 to 4 months for the first 2 years, and every 6 months for the 3rd year. | — |
Countries
India
Contacts
Public ContactDR Indraja Devidas Dev
ADVANCED CENTRE FOR TREATMENT RESEARCH AND EDUCATION IN CANCER TATA MEMORIAL CENTRE
Outcome results
None listed