Feasibility of 5-ALA and Carmustine wafers for Glioblastoma (GALA-5)

• Research type

  Research Study

• Full title

  An Evaluation of the Tolerability and Feasibility of combining 5-Amino-Levulinic Acid (5-ALA) with Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma (GALA-5 Trial)

• IRAS ID

  67255

• Contact name

  Colin Watts

• Sponsor organisation

  Joint UCLH and UCL Biomedical Research Unit

• Eudract number

  2010-022496-66

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Glioblastoma (GBM) is the commonest brain tumour in adults. The combination of surgical cytoreduction (removal of the tumour), concomitant chemoradiation (chemotherapy given at the same time as radiotherapy) and adjuvant chemotherapy (chemotherapy given after the chemoradiotherapy) leads to a median survival of 15 months and 2-year survival of 27%. Aminolevulinic acid hydrochloride (5-aminolevulinic acid HCl; 5-ALA; Gliolan) is a pro-drug that leads to the selective accumulation of thflurescent compound protoporphyrin IX (PPIX) in GBM. This can be visualised under blue light enabling objective surgical resection and improved progression-free survival. Carmustine wafers (Gliadel) are biodegradable copolymer discs impregnated with the alkylating agent carmustine that are implanted into the resection cavity at the end of surgery. They have a modest impact on survival of GBM patients but have yet to be evaluated in combination witflurescence guided resection. The aim of this study is to establish the safety, tolerability and feasibility of combininflurescence-guided surgical tumour resection with intra-operative chemotherapy in GBM patients eligible to proceed onto chemo-radiotherapy. Patients with suspected primary GBM in whom complete resection is considered feasible will be given 5-ALA. They will then receive carmustine implants. Primary outcomes will include neurosurgical complications and evaluation of time to start and complete radiotherapy and chemotherapy. Secondary outcome measures will be survival at 24 months and time to progression

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/100

• Date of REC Opinion

  21 Feb 2011

• REC opinion

  Further Information Favourable Opinion