Primary glioblastoma MedDRA version: 14.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gliolan
Product Name: Gliolan, 5-ALA
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: 5-Aminolevulinic acid hydrochloride
CAS Number: 5451-09-2
Other descriptive name: 5-
Sponsors
Joint UCLH and UCL Biomedical Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish that the combined use of 5-ALA and Carmustine wafers is safe and does not compromise a patient from receiving or completing standard chemo-radiotherapy.;Secondary Objective: To gather preliminary evidence that the combined use of 5-ALA and Carmustine wafers at surgery has the potential to improve clinical outcome. The following questions will be addressed: * What is the time to clinical progression? * What is the survival at 24 months?;Primary end point(s): The primary objective of the study is to establish that the combined use of 5-ALA and Carmustine wafers is safe and does not compromise a patient from completing or receiving standard chemoRT. This will be measured using the following endpoints: • Procedure compliance: Proportion of 5-ALA resected patients who received Carmustine wafer implants (e.g to take into account rates of patients who did not receive Carmustine wafer implants due to 1) ventricular breach, 2) inaccurate peri-operative diagnosis, 3) intra-operative surgical decision) • Post-operative complication rate: Proportion of patients with a new post-operative deficit or surgical complication (wound infection, CSF leakage, intracranial hypertension) • Number of patients with chemoRT delay (i.e number who do not begin chemoRT 6 weeks after surgery) due to surgical complications* • Number of patients failing to start chemoRT due to surgical complications rather than tumour progression • Number of patients failing to complete chemoRT without interruption (RT with concomitant chemotherapy, and RT with concomitant plus adjuvant chemotherapy) • Proportion of patients with a lower WHO performance status after surgery with Carmustine wafers (at first post-operative clinic visit) Standard chemoRT refers to the Stupp regimen of 60Gy in 30 fractions + 75mg/m2 daily temozolomide (TMZ) during radiotherapy (over 6 weeks) (RT with concomitant chemotherapy), followed by a 4 week break and then 6 cycles TMZ (adjuvant chemotherapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Time to Clinical Progression * Survival at 24 months;Timepoint(s) of evaluation of this end point: At the end of the trial and after 24 months after end of recruitment recruitment. | — |
Countries
United Kingdom
Outcome results
None listed