Brain and Central Nervous System Tumors Clinical Trial
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
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - 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 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 - 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) |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrooke's Hospital | Cambridge | England |
United Kingdom | Western General Hospital | Edinburgh | |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | Scotland |
United Kingdom | St James' University Hospital | Leeds | |
United Kingdom | UCL Cancer Institute | London | England |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | Southampton General Hospital | Southampton | England |
Lead Sponsor | Collaborator |
---|---|
Cancer Research UK | Immatics Biotechnologies Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | ||
Primary | 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 | No | ||
Secondary | 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 | No | ||
Secondary | Correlation between steroid levels and observed T-cell responses | No | ||
Secondary | 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) | No | ||
Secondary | Kinetics of vaccine-induced TUMAP responses including summary descriptions of the time of onset, sustainability, and magnitude of the observed response | No |
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