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| Sponsor: | Cancer Research UK |
|---|---|
| Information provided by (Responsible Party): | Cancer Research UK |
| ClinicalTrials.gov Identifier: | NCT01222221 |
Purpose
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as 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 vaccine therapy together with temozolomide and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: glioblastoma multiforme multipeptide vaccine IMA950 Biological: sargramostim Drug: temozolomide Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Cancer Research UK Phase I Trial of IMA950 (A Novel Multi-Peptide Vaccine) Plus GM-CSF in Patients With Newly Diagnosed Glioblastoma |
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed glioblastoma multiforme (astrocytoma WHO grade IV disease)
Meets 1 of the following criteria regarding standard chemoradiotherapy:
Cohort 1
Eligible for standard chemoradiotherapy with temozolomide followed by adjuvant temozolomide
Cohort 2
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior treatment for glioblastoma including Gliadel Wafers
Contacts and Locations| United Kingdom | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Contact Person 44-122-358-6705 sarah.jefferies@addenbrookes.nhs.uk | |
| UCL Cancer Institute | Recruiting |
| London, England, United Kingdom, WC1E 6DD | |
| Contact: Contact Person 44-20-7380-3762 paul.mulholland@nhs.net | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Contact Person 44-23-8079-8657 omar.alsalihi@suht.swest.nhs.uk | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Contact: Contact Person 44-141 301 7069 allan.james@ggc.scot.nhs.uk | |
| Western General Hospital | Recruiting |
| Edinburgh, United Kingdom, EH4 2XU | |
| Contact: Contact Person 0131 537 1000 Sharon.peoples@luht.scot.nhs.uk | |
| St James' University Hospital | Recruiting |
| Leeds, United Kingdom, LS9 7TF | |
| Contact: Contact Person 0113 20 68186 c.j.twelves@leeds.ac.uk | |
| The Christie NHS Foundation Trust | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Contact: Contact Person 0161 446 3495 catherine.mcbain@christie.nhs.uk | |
| Principal Investigator: | Roy Rampling, MD, PhD | University of Glasgow |
More Information
| Responsible Party: | Cancer Research UK |
| ClinicalTrials.gov Identifier: | NCT01222221 History of Changes |
| Other Study ID Numbers: | CDR0000686559, CRUK-CR0902-11, EUDRACT-2009-015971-28 |
| Study First Received: | October 14, 2010 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
|
adult gliosarcoma adult giant cell glioblastoma adult glioblastoma |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |