Know Cancer

or
forgot password

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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

Thank you

Trial Information

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)


OBJECTIVES:

Primary

- To establish that the combined use of 5-ALA and Gliadel wafers during
fluorescence-guided radical brain tumor resection is safe and does not compromise
patients with primary glioblastoma from receiving or completing adjuvant standard
radiotherapy plus temozolomide.

Secondary

- To gather preliminary evidence that the combined use of 5-ALA and Gliadel wafers at
surgery has the potential to improve clinical outcome, via measurement of time to
clinical progression.

- To gather preliminary evidence that this regimen at surgery has the potential to
improve clinical outcome via measurement of survival at 24 months.

OUTLINE: This is a multicenter study.

Gliadel wafers are applied to resection cavity immediately after 5-ALA fluorescence-guided
radical brain tumor resection. After recovery from surgery (within 6 weeks of surgery when
possible ), patients receive adjuvant chemoradiotherapy comprising standard radiotherapy and
temozolomide.

Tumor biopsy and blood sample may be collected at time of surgery for retrospective MGMT
status analysis.

After surgery, patients are followed up at post-surgical visits, during subsequent therapy
at routine clinic visits, and at 12, 18, and 24 months.

Peer reviewed and funded by Cancer Research UK.

Inclusion Criteria


INCLUSION CRITERIA

i. The patient is reviewed at a specialist neuro-oncology multi-disciplinary team (MDT).

ii. Stealth MRI (neuronavigation) will be performed prior to surgery.

iii. Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of
a primary GBM

iv. 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)

v. WHO performance status 0 or 1

vi. Age ≥18

vii. 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

i. GBM thought to be transformed low grade or secondary disease

ii. The patient has not been seen by a specialist MDT.

iii. There is uncertainty about the radiological diagnosis

iv. 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)

v. Pregnant or lactating women

vi. Known or suspected HIV or other significant infection or comorbidity that would
preclude radical aggressive therapy for GBM

vii. Active liver disease (ALT or AST ≥5 x ULRR)

viii. Concomitant anti-cancer therapy except steroids

ix. History of other malignancies (except for adequately treated basal or squamous cell
carcinoma or carcinoma in situ) within 5 years

x. Previous brain surgery (including biopsy) or cranial radiotherapy

xi. Platelets <100 x109/L

xii. Mini mental status score <15

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability, and feasibility of combination intra-operative 5-ALA and Gliadel wafers prior to adjuvant radiotherapy plus temozolomide

Outcome Time Frame:

Date of surgery to end of temozolomide and radiotherapy treatment

Safety Issue:

Yes

Principal Investigator

Colin Watts

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cambridge University Hospitals NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CDR0000696316

NCT ID:

NCT01310868

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Glioblastoma

Name

Location