ATNT-05INTRAOPERATIVE INTRAPARENCHYMAL INJECTION OF IRINOTECAN DRUG LOADED BEADS IN PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM): A SAFE NEW DEPOT APPROACH FOR LOCO-REGIONAL THERAPY (NCT02433392)

Autor: A. Detta, Desire Ngoga, Juliet Connor, Oluwafikayo Fayeye, Garth Cruickshank
Rok vydání: 2015
Předmět:
Zdroj: Neuro-Oncology. 17:v11.1-v11
ISSN: 1523-5866
1522-8517
DOI: 10.1093/neuonc/nov205.05
Popis: BACKGROUND: Chemotherapy for brain tumours has been limited because of difficulty in achieving exposure to the tumour without systemic toxicity. Parenteral Irinotecan despite activity against glioma has an uncertain entry into the brain that has questioned its actual efficacy against glioma and a poor profile of enhanced systemic toxicity. In this study we have injected irinotecan sulphonated to PVA beads (1-1000 ) into the brain around tumour following resection of recurrent GBM to assess vehicle and drug safety from disease and procedure related problems. METHODS:10 patients who have failed available therapy for proven recurrent GBM with single focal recurrences as determined by gadolinium enhanced MRI with good performance and ages from 34 -76 were consented for this Phase I study. At operation tumour was removed and the cavity wall injected up to 5mm depth with up to 60 injections of beads suspended in alginate solution delivered using a 24 gauge flexible catheter to a total volume of 3mls and a drug dose of 100mg. Clinical assessments and blood samples were assessed for CTC criteria over 5/7 and imaging and clinical a assessment performed post operation at two and four and eight weekly to 6 months post surgery. RESULTS: To date one (6/15) patient has died at 4/12post treatment of progressive disease and there have been no CTC >2 or procedure related falls in performance despite these patients previous treatment and condition. We have no evidence from this study to suggest any local chemical meningitis or untoward swelling from the injection process. Follow-up is ongoing for survival comparison with other depot therapies. CONCLUSIONS: This novel form of depot therapy offers a stable safe drug loading platform and an accessible generic approach to ensuring local delivery of new agents or those with an uncertain access profile.
Databáze: OpenAIRE