Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII
NCT00643097CI-TRIAL-00025740ACTIVATecompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms of Brain | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP-3 vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (ACTIVATE)
- description
- Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)-specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF), referred to as PEP-3 vaccine, every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
- interventionNames
- Biological: PEP-3 vaccine
- Biological: sargramostim
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Arm II (ACT II STD)
- description
- Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF), referred to as PEP-3 vaccine, biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (3)
- RESULTSchmittling RJ, Archer GE, Mitchell DA, Heimberger A, Pegram C, Herndon JE 2nd, Friedman HS, Bigner DD, Sampson JH. Detection of humoral response in patients with glioblastoma receiving EGFRvIII-KLH vaccines. J Immunol Methods. 2008 Nov 30;339(1):74-81. doi: 10.1016/j.jim.2008.08.004. Epub 2008 Sep 4. PMID 18775433
- RESULTSampson JH, Heimberger AB, Archer GE, Aldape KD, Friedman AH, Friedman HS, Gilbert MR, Herndon JE 2nd, McLendon RE, Mitchell DA, Reardon DA, Sawaya R, Schmittling RJ, Shi W, Vredenburgh JJ, Bigner DD. Immunologic escape after prolonged progression-free survival with epidermal growth factor receptor variant III peptide vaccination in patients with newly diagnosed glioblastoma. J Clin Oncol. 2010 Nov 1;28(31):4722-9. doi: 10.1200/JCO.2010.28.6963. Epub 2010 Oct 4. PMID 20921459
- RESULTSampson JH, Aldape KD, Archer GE, Coan A, Desjardins A, Friedman AH, Friedman HS, Gilbert MR, Herndon JE, McLendon RE, Mitchell DA, Reardon DA, Sawaya R, Schmittling R, Shi W, Vredenburgh JJ, Bigner DD, Heimberger AB. Greater chemotherapy-induced lymphopenia enhances tumor-specific immune responses that eliminate EGFRvIII-expressing tumor cells in patients with glioblastoma. Neuro Oncol. 2011 Mar;13(3):324-33. doi: 10.1093/neuonc/noq157. Epub 2010 Dec 10. PMID 21149254