Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed · Phase 2

Conditions studied: Malignant Neoplasms of Brain

In brief

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme.

Key facts

Study ID

NCT00643097

Run by

John Sampson

People needed

40

Starts

2007-09-01

Expected to finish

2016-11-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed newly diagnosed glioblastoma multiforme
• Has undergone prior gross total resection (GTR) followed by conformal radiotherapy* with or without concurrent chemotherapy
• GTR is defined as ≥ 95% volumetric resection of the contrast-enhancing component on the preoperative MRI
• Residual radiographic contrast enhancement on post-resection CT scan or MRI must be ≤ 1 cm in maximal diameter in any two perpendicular axial planes
• No evidence of disease progression after completion of radiotherapy* NOTE: *Patients may enroll in part 2 of the study within 2 weeks after surgery; these patients will receive radiotherapy with concurrent chemotherapy during the study
• EGFRvIII-positive tumor by immunohistochemistry, polymerase chain reaction, or related molecular techniques
• Karnofsky performance status 80-100%
• Curran group status I-IV
• Signed informed consent form

You may not qualify if…

• Absolute Neutrophil Count (ANC) < 1,000/mm³
• Platelet count < 50,000/mm³
• Prothrombin Time/Partial Thromboplastin Time (PT/PTT) > 1.5 times normal
• Positive hepatitis B (HB) surface antigen (HbsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc)
• Pregnant or nursing
• Positive pregnancy test
• Active infection requiring treatment
• Unexplained febrile illness (T max > 101.5 F)
• Inflammatory bowel disease, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease
• Known immunosuppressive disease
• Known HIV infection
• Diffuse leptomeningeal disease
• Unstable or severe concurrent medical condition, such as severe heart and lung disease or active hepatitis
• Demonstrated allergy to temozolomide or inability to tolerate temozolomide for reasons other than lymphopenia
• Concurrent corticosteroids (except for nasal or inhaled steroids) at a dose above physiologic levels (> 2 mg of dexamethasone/day).

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• M. D. Anderson Cancer Center at University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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