Clinical Trial Details
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[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01222221 : Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
PhasePhase 1
AgesMin: 18 Years Max: N/A

- 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

- 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

- 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

- 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)
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