Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Sampson
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Keyhole-limpet hemocyanin; Sargramostim; Temozolomide; Vaccines

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).