Status:
COMPLETED
Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme
Lead Sponsor:
John Sampson
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Central Nervous System Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side eff...
Detailed Description
OBJECTIVES: Primary * To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent g...
Eligibility Criteria
Inclusion
- Age \>18 years of age
- First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of GBM
- No known contraindications to receiving Avastin
- Karnofsky Performance Status (KPS) of \> 70%
- Radiation Therapy (RT) with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry
Exclusion
- Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)
- Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Pregnant or need to breast feed during the study period (Negative beta-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study
- Active infection requiring treatment or an unexplained febrile (\> 101.5 degrees F) illness
- Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C
- Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 \< 50%) disease, uncontrolled diabetes mellitus
- Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery
- Prior inguinal lymph node dissection
- Avastin-Specific Exclusion Criteria
- Subjects meeting any of the following criteria are ineligible for study entry:
- Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to enrollment
- History of stroke or transient ischemic attack within 6 months prior to enrollment
- Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment)
- History of hemoptysis (\> or = 1/2 teaspoon of bright red blood per episode) within 28 days prior to enrollment
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment
- Serious, non-healing wound, active ulcer or untreated bone fracture
- Proteinuria as defined by \> +1 on urinalysis dipstick
- Known hypersensitivity to any component of Avastin
- Pregnant (positive pregnancy test) or lactation
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00890032
Start Date
September 1 2009
End Date
February 1 2016
Last Update
October 17 2016
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710