Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: 5-ALA Drug: Gliadel wafers |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Survival at 24 months [ Time Frame: from the date of surgery to 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5-ALA and Gliadel wafers
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.
|
Drug: 5-ALA
5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
Other Names:
Drug: Gliadel 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.
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lizzie Roberts | 02076799116 | ctc.gala5@ucl.ac.uk |
| United Kingdom | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Contact Person 44-1223-762-092 cw209@cam.ac.uk | |
| Royal Preston Hospital | Recruiting |
| Preston, Lancashire, United Kingdom | |
| Contact: Charles Davis charles.davis@lthtr.nhs.uk | |
| Principal Investigator: Charles Davis | |
| Ninewells Hospital | Recruiting |
| Dundee, United Kingdom | |
| Contact: Sam Eljamel sam.eljamel@nhs.net | |
| Principal Investigator: Sam Eljamel | |
| Southern General Hospital | Recruiting |
| Glasgow, United Kingdom | |
| Contact: Likhith Alakandy likhith.alakandy@nhs.net | |
| Principal Investigator: Likhith Alakandy | |
| Hull Royal Infirmary | Not yet recruiting |
| Hull, United Kingdom | |
| Contact: Shailendra Achawal Shailendra.Achawal@hey.nhs.uk | |
| Principal Investigator: Shailendra Achawal | |
| Leeds General Infirmary | Not yet recruiting |
| Leeds, United Kingdom | |
| Contact: Simon Thomson simon.thomson@leedsth.nhs.uk | |
| Principal Investigator: Simon Thomson | |
| The Walton Centre | Recruiting |
| Liverpool, United Kingdom | |
| Contact: Michael Jenkinson michael.jenkinson@thewaltoncentre.nhs.uk | |
| Principal Investigator: Michael Jenkinson | |
| King's College Hospital | Recruiting |
| London, United Kingdom | |
| Contact: Keyoumars Ashkan k.ashkan@nhs.net | |
| Principal Investigator: Keyyoumars Ashkan | |
| University College London Hospital/ National Hospital for Neurology and Neurosurgery | Recruiting |
| London, United Kingdom | |
| Contact: Paul Mulholland, PhD, MRCP, MSC, MBBS paul.mulholland@nhs.net | |
| Principal Investigator: Paul Mulholland | |
| Royal Hallamshire Hospital | Not yet recruiting |
| Sheffield, United Kingdom | |
| Contact: David Jellinek david.jellinek@sth.nhs.uk | |
| Principal Investigator: David Jellinek | |
| Principal Investigator: | Colin Watts | Cambridge University Hospitals NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT01310868 History of Changes |
| Other Study ID Numbers: | CDR0000696316, CRUK-UCL-09-0398, 2010-022496-66, 09/0398, 10/H0304/100 |
| Study First Received: | March 5, 2011 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University College, London:
|
adult giant cell glioblastoma adult gliosarcoma adult glioblastoma |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Aminolevulinic Acid Carmustine |
Levulinic acid Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013