Status:
COMPLETED
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
John Sampson
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Malignant Neoplasms of Brain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
OBJECTIVES: Primary * To assess humoral and cellular immune responses to adjuvant PEP-3-KLH conjugate vaccine in patients with newly diagnosed glioblastoma multiforme (GBM). * To assess the clinical...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00643097
Start Date
September 1 2007
End Date
November 1 2016
Last Update
February 1 2017
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009