NCT01310868

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)

Completed Phase 2 Results posted Last updated 6 September 2017

What this trial tests

Phase 2 trial testing 5-ALA in Glioblastoma in 59 participants. Completed in 1 March 2015.

Timeline

1 May 2011

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	University College, London
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	1 May 2011
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	10 locations across United Kingdom

Drugs / interventions tested

• 5-ALA — full drug profile →
• Gliadel wafers — full drug profile →
• Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
• Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
• Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

University College, London

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 (up to 34 weeks)
  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 surgic

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Challenges and opportunities to penetrate the blood-brain barrier for brain cancer therapy.
   Upton DH, Ung C, George SM, Tsoli M, et al · · 2022 · cited 96× · PMID 35832071 · DOI 10.7150/thno.69682
2. Unique biology of gliomas: challenges and opportunities.
   Watkins S, Sontheimer H. · · 2012 · cited 53× · PMID 22683220 · DOI 10.1016/j.tins.2012.05.001
3. The Importance of Tumor Stem Cells in Glioblastoma Resistance to Therapy.
   Mattei V, Santilli F, Martellucci S, Delle Monache S, et al · · 2021 · cited 49× · PMID 33917954 · DOI 10.3390/ijms22083863
4. Breaching the Blood-Brain Tumor Barrier for Tumor Therapy.
   Marcucci F, Corti A, Ferreri AJM. · · 2021 · cited 30× · PMID 34063335 · DOI 10.3390/cancers13102391
5. Image-Guided Tumor Resection.
   Parrish-Novak J, Holland EC, Olson JM. · · 2015 · cited 14× · PMID 26049700 · DOI 10.1097/ppo.0000000000000113
6. Role of glioma stem cells in promoting tumor chemo- and radioresistance: A systematic review of potential targeted treatments.
   Agosti E, Zeppieri M, Ghidoni M, Ius T, et al · · 2024 · cited 9× · PMID 38817336 · DOI 10.4252/wjsc.v16.i5.604
7. Development of regional chemotherapies: feasibility, safety and efficacy in clinical use and preclinical studies.
   Cai S, Bagby TR, Forrest ML. · · 2011 · cited 5× · PMID 22229080 · DOI 10.4155/tde.11.112
8. An Evaluation of the Tolerability and Feasibility of Combining 5-Amino-Levulinic Acid (5-ALA) with BCNU Wafers in the Surgical Management of Primary Glioblastoma.
   Watts C, Ashkan K, Jenkinson MD, Price SJ, et al · · 2021 · cited 3× · PMID 34209555 · DOI 10.3390/cancers13133241