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

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Brain Tumour; Disease: Brain and Nervous System; Cancer

• Registration Number: ISRCTN77105850
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-21
• Study Completion: 2013-05-01
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. The patient is reviewed at a specialist neuro-oncology multi-disciplinary team (MDT).
2. Preop MRI should be carried out, ideally on no or stable steroids according to RANO criteria
3. Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM
4. 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)
5. WHO performance status 0 or 1
6. Age =18
7. Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide)

Exclusion Criteria

1. GBM thought to be transformed low grade or secondary disease
2. The patient has not been seen by a specialist MDT.
3. There is uncertainty about the radiological diagnosis
4. 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)
5. Pregnant or lactating women
6. Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM
7. Active liver disease (ALT or AST =5 x ULRR)
8. Concomitant anti-cancer therapy except steroids
9. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years
10. Previous brain surgery (including biopsy) or cranial radiotherapy
11. Platelets <100 x109/L
12. Mini mental status score <15

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. % 5-ALA resected patients receiving Carmustine wafers<br> 2. Post operative complication rate<br> 3. No. patients with delay (> 6 weeks) to receiving chemoRT due to surgical complications<br> 4. No. patients failing to receive chemoRT due to surgical complications<br> 5. No. patients failing to complete chemoRT without interruption<br> 6. % patients with a lower WHO performance status after surgery with Carmustine wafers<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Time to Clinical Progression<br> 2. Survival at 24 months<br>