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Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01222221
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : October 14, 2015
Immatics Biotechnologies GmbH
Information provided by (Responsible Party):
Cancer Research UK

Brief Summary:

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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Primary Outcome Measures :
  1. Causality of each adverse event (AE) to glioblastoma multiform multi-antigen vaccine IMA950 and GM-CSF and AE severity according to NCI CTCAE Version 4.0
  2. Total number of patients showing patient-individual T-cell responses against a single or multiple tumor-associated peptides (TUMAP) contained in the study vaccine IMA950 at one or more post-vaccination time points by HLA multimer analysis

Secondary Outcome Measures :
  1. Progression-free survival (PSF) at 6 and 9 months post-surgery as assessed by the Macdonald criteria from conventional gadolinium-enhanced MRI and clinical assessment
  2. Correlation between steroid levels and observed T-cell responses
  3. Correlation between O6-methyl-DNA-methyltransferase (MGMT) promoter methylation status in tumor tissue using methylation-specific polymerase chain reaction and clinical benefit (PFS at 6 months and 9 months)
  4. Kinetics of vaccine-induced TUMAP responses including summary descriptions of the time of onset, sustainability, and magnitude of the observed response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed glioblastoma multiforme (astrocytoma WHO grade IV disease)

    • Newly diagnosed disease
    • Resectable tumor (not including patients undergoing biopsy only or tumors involving the brain stem or cerebellum)
  • Meets 1 of the following criteria regarding standard chemoradiotherapy:

    • Cohort 1

      • Eligible for standard chemoradiotherapy with temozolomide followed by adjuvant temozolomide

        • Has undergone surgical resection before study enrollment
    • Cohort 2

      • Completed standard chemoradiotherapy with temozolomide with no subsequent progression of disease
  • Expected to complete standard chemoradiotherapy and 6 courses of adjuvant temozolomide
  • HLA-A*02 positive


  • WHO performance status 0-1
  • Life expectancy ≥ 30 weeks
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Lymphocyte count ≥ 1.0 x 10^9/L (cohort 1) OR ≥ 0.35 x 10^9/L post-chemoradiotherapy and ≥ 1.0 x 10^9/L prior to the start of chemoradiotherapy (cohort 2)
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT or AST ≤ 3.0 times ULN
  • Alkaline phosphatase ≤ 3.0 times ULN
  • Hepatitis B serology negative (HBcAg-seronegative)
  • No known hepatitis C or HIV serological positivity
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use one (male) or two (female) highly effective forms of contraception 2 weeks before, during, and for 6 months after completion of study therapy
  • Not at high medical risk due to nonmalignant systemic disease including active uncontrolled infection
  • No known hypersensitivity to GM-CSF or excipients
  • No history of autoimmune disease
  • No concurrent congestive heart failure
  • No prior history of NYHA class III-IV cardiac disease, cardiac ischemia, or cardiac arrhythmia
  • No other condition that might interfere with the patient's ability to generate an immune response
  • No other condition that, in the investigator's opinion, would make the patient not a good candidate for the clinical trial


  • See Disease Characteristics
  • At least 7 days since prior dexamethasone (dose > 4 mg daily or equivalent)
  • At least 4 weeks since prior major surgery for any condition (except surgical resection as part of primary standard therapy in cohort 1)
  • At least 30 days since prior and no concurrent participation in another clinical trial or planning to participate in another interventional clinical trial (concurrent participation on an observational study allowed)
  • At least 30 days since prior and no other concurrent investigational drugs
  • No prior treatment for glioblastoma including Gliadel Wafers

    • Early components of standard therapy are allowed if already initiated (i.e., surgical resection [cohort 1] or surgical resection followed by conventional external-beam radiotherapy and concomitant temozolomide [cohort 2])
  • No other concurrent anticancer therapy
  • No other concurrent vaccinations from 2 weeks before the first study vaccine to the end of the sixth study vaccine (the induction phase)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222221

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United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
UCL Cancer Institute
London, England, United Kingdom, WC1E 6DD
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
St James' University Hospital
Leeds, United Kingdom, LS9 7TF
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Cancer Research UK
Immatics Biotechnologies GmbH
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Principal Investigator: Roy Rampling, MD, PhD University of Glasgow
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Responsible Party: Cancer Research UK
ClinicalTrials.gov Identifier: NCT01222221    
Other Study ID Numbers: CDR0000686559
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Cancer Research UK:
adult gliosarcoma
adult giant cell glioblastoma
adult glioblastoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs