Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-005315
NCT ID: NCT01814813
Sponsor Protocol Number: A071101
About this study
This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
Pre-registration (Pre-Surgery) Eligibility Criteria
- Histologic documentation: Prior histologic diagnosis of GBM at first occurrence.
- Stage: First or second recurrence of GBM considered to be surgically resectable.
- Prior Treatment:
- No radiotherapy within 90 days prior to pre-registration.
- No prior treatment with any anti-angiogenic agent targeting the VEGF pathway including but not limited to bevacizumab, cediranib, vandetanib, sunitinib,pazopanib, aflibercept, or sorafenib
- No prior treatment with HSPPC-96 or other investigational immunotherapy.
- Must have received prior treatment with radiotherapy and temozolomide for histologically confirmed GBM at initial diagnosis.
- No tumor directed therapy for most recent progression.
- No prior Gliadel® wafers.
- No clinically significant cardiovascular disease:
- Patients with a history of hypertension must be well controlled (<150/90) on a regimen of antihypertensive therapy.
- History of arterial thrombotic events within the past 6 months, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medial intervention in the past 6 months, or myocardial infarction (MI).
- Patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection) are not eligible. Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation
- No current New York Heart Association classification II, III or IV congestive heart failure
- No significant bleeding within the past 6 months; no bleeding diathesis or coagulopathy
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months
- No evidence of any systemic autoimmune disease (e.g. Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
- Age ≥ 18 years of age
- Karnofsky functional status rating ≥70
- No more than 16 mg dexamethasone (or equivalent) per day
- Non-pregnant and non-nursing
Registration (Post-Surgery) Eligibility Criteria
- Pre-registration eligibility criteria continue to be met
- Histologic documentation: confirmed histological diagnosis of recurrent GBM
- ≥ 90% surgical resection of recurrent GBM confirmed by central radiology review by MRI with or without gadolinium per institutional guidelines. A CT scan is allowable in place of MRI only in situations where an MRI is contraindicated (e.g., patient has a heart pacemaker, metallic devices in the eye, brain or spine, severe claustrophobia).
- ≥ 9 grams of resected tumor available for vaccine manufacture as determined by institutional pathologist
- Availability of ≥ 6 clinical vials of HSPPC-96
- Required Initial Laboratory Values:
- Granulocytes ≥1,500/µL
- Platelet count ≥100,000/µL
- Total Bilirubin ≤ 2.0 x ULN
- UPC ratio <1 OR
- Urine protein ≤ 1+
- Calculated creatinine clearance ≥45 ml/min
- SGOT/SGPT(AST/ALT) ≤ 2.5 x ULN
- No serious, non-healing wounds or ulcers
- At least 7 days since any minor surgery such as port placement
- No major surgical procedures, open biopsy or significant traumatic injury ≤ 28 days prior to registration or anticipation of need for elective or planned major surgical procedure during the study. Core biopsy or other minor surgical procedures ≤7 days prior to registration.
- No active or recent hemoptysis (≥½ teaspoon of bright red blood per episode) ≤30 days prior to registration.
- No new bleeding on D28 (+/3) MRI (or CT if MRI is contraindicated)
- No clinical deterioration at the time of registration/randomization
- If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Ian Parney, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office