Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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ClinicalTrials.gov Identifier: NCT01222221 |
Recruitment Status :
Completed
First Posted : October 18, 2010
Last Update Posted : October 14, 2015
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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 |

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 |

- 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
- 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
- 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
- Correlation between steroid levels and observed T-cell responses
- 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)
- Kinetics of vaccine-induced TUMAP responses including summary descriptions of the time of onset, sustainability, and magnitude of the observed response

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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)
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Meets 1 of the following criteria regarding standard chemoradiotherapy:
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Cohort 1
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Eligible for standard chemoradiotherapy with temozolomide followed by adjuvant temozolomide
- Has undergone surgical resection before study enrollment
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Cohort 2
- Completed standard chemoradiotherapy with temozolomide with no subsequent progression of disease
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- Expected to complete standard chemoradiotherapy and 6 courses of adjuvant temozolomide
- HLA-A*02 positive
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
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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)

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
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 |
Principal Investigator: | Roy Rampling, MD, PhD | University of Glasgow |
Responsible Party: | Cancer Research UK |
ClinicalTrials.gov Identifier: | NCT01222221 |
Other Study ID Numbers: |
CDR0000686559 CRUK-CR0902-11 EUDRACT-2009-015971-28 |
First Posted: | October 18, 2010 Key Record Dates |
Last Update Posted: | October 14, 2015 |
Last Verified: | October 2015 |
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 Sargramostim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |