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Status:

COMPLETED

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

Lead Sponsor:

Cancer Research UK

Collaborating Sponsors:

Immatics Biotechnologies GmbH

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 gr...

Detailed Description

OBJECTIVES: Primary * To assess the safety and tolerability of glioblastoma multiform multi-antigen vaccine IMA950 plus sargramostim (GM-CSF) in combination with standard chemoradiotherapy comprisin...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    July 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2015

    Estimated Enrollment :

    45 Patients enrolled

    Trial Details

    Trial ID

    NCT01222221

    Start Date

    July 1 2010

    End Date

    February 1 2015

    Last Update

    October 14 2015

    Active Locations (7)

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    Page 1 of 2 (7 locations)

    1

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ

    2

    UCL Cancer Institute

    London, England, United Kingdom, WC1E 6DD

    3

    Southampton General Hospital

    Southampton, England, United Kingdom, SO16 6YD

    4

    Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, United Kingdom, G12 0YN