An evaluation of the tolerability and feasibility of combining 5-Amino-Levu... | Not Recruiting
An evaluation of the tolerability a... | Not Recruiting
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

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Brain Tumour
  • Disease: Brain and Nervous System
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN77105850

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Summary
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-5ala-and-gliadel-wafers-as-part-of-treatment-for-glioblastoma-gala5
Research Details
  • 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; 5ALA;
    Gliolan) is a prodrug that leads to the selective accumulation of the fluorescent 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 with fluorescence guided resection.

    The aim of this study is to establish the safety, tolerability and feasibility of combining fluorescence-guided surgical tumour resection with intraoperative chemotherapy in GBM patients eligible to proceed onto chemoradiotherapy.

    Patients with suspected primary GBM in whom complete resection is considered feasible will be given 5-ALA. They will then receive carmustine implants.

    A protocol summary can be downloaded from the trial website: http://www.ctc.ucl.ac.uk/TrialDetails.aspx?TrialID=50

    More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9566
Phase
Phase II
Study Design
Non-randomised interventional treatment trial
Study Type
Interventional
Intervention

1. 60 patients are required to receive both Gliolan and Gliadel wafers for the trial
2. The trial will stop recruiting once 60 patients have received both treatments
3. The global sample size has been set at 120 patients on the portfolio to account for a 50% rate of failure to administer Gliadel wafers (e.g to patients with complications or those who are found to be ineligible during surgery)
4. 5-ALA (Gliolan) used to guide resection
5. Gliadel wafers are inserted into tumour cavity at the end of resection

Intervention Type
Drug
Primary Outcome Measures
    1. % 5-ALA resected patients receiving Carmustine wafers
    2. Post operative complication rate
    3. No. patients with delay (> 6 weeks) to receiving chemoRT due to surgical complications
    4. No. patients failing to receive chemoRT due to surgical complications
    5. No. patients failing to complete chemoRT without interruption
    6. % patients with a lower WHO performance status after surgery with Carmustine wafers
Secondary Outcome Measures
    1. Time to Clinical Progression
    2. Survival at 24 months
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
UK Sample Size: 120
Participant 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)
Participant 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W1T 4TJ
Trial Contact(s)
Primary Trial Contact
Dr Fiona Dungey
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
2010-022496-66
Funder(s)
  • Cancer Research UK
  • Samantha Dickson Brain Tumour Trust
Other Study ID Numbers
9566
Sponsor(s)
University College London (UK)
Key Dates

Recruitment Start Date

01 May 2011

Recruitment End Date

01 May 2013

Trial Start Date

01 May 2011

Trial End Date

01 May 2013

Date added to source

21 Jun 2011

Date updated in source

16 Feb 2016