Overview

This trial is active, not recruiting.

Condition glioblastoma
Treatments 5-ala, gliadel wafers
Phase phase 2
Sponsor University College, London
Start date May 2011
End date February 2016
Trial size 60 participants
Trial identifier NCT01310868, 09/0398, 10/H0304/100, 2010-022496-66, CDR0000696316, CRUK-UCL-09-0398

Summary

RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery with 5-ALA given together with Gliadel wafer, followed by radiation therapy and temozolomide, in treating patients with primary glioblastoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
5-ala Amino-levulinic Acid
5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
gliadel wafers Carmustine wafers
The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.

Primary Outcomes

Measure
Safety, tolerability, and feasibility of combination intra-operative 5-ALA and Gliadel wafers prior to adjuvant radiotherapy plus temozolomide
time frame: Date of surgery to end of temozolomide and radiotherapy treatment

Secondary Outcomes

Measure
Time to clinical progression
time frame: from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported
Survival at 24 months
time frame: from the date of surgery to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official 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)
Principal investigator Colin Watts
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University College, London.