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

Conditions: Primary glioblastoma
MedDRA version: 14.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2010-022496-66-GB

Lead Sponsor: Joint UCLH and UCL Biomedical Research Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• The patient is reviewed at a specialist neuro-oncology MDT. • Preop stealth MRI should be carried out on no or stable steroids according to RANO criteria • Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM • Radical resection is judged to be realistic by the neurosurgeons at the MDT (i.e. NICE criteria for the use of Carmustine wafers can be met) • WHO performance status 0 or 1 • Age =18 • Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• GBM thought to be transformed low grade or secondary disease • The patient has not been seen by a specialist MDT. • There is uncertainty about the radiological diagnosis • 5-ALA or Carmustine wafers is contra-indicated (inc known or suspected allergies to 5-ALA or porphyrins, or acute or chronic types of porphyria) • Pregnant or lactating women • Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM • Active liver disease (ALT or AST =5 x ULRR) • Concomitant anti-cancer therapy except steroids • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years • Previous brain surgery (including biopsy) or cranial radiotherapy • Platelets <100 x10_9/L • Mini mental status score <15