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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK
• Collaborator: immatics Biotechnologies GmbH
• Treatments: Sargramostim; Temozolomide; Vaccines

Criteria

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)