Trial record 5 of 13 for:
Open Studies | "Neuroma, Acoustic"
Intraarterial Cerebral Infusion of Avastin for Vestibular Schwannoma (Acoustic Neuroma)
This study is currently recruiting participants.
Verified December 2012 by Weill Medical College of Cornell University
Information provided by (Responsible Party):
John A. Boockvar, Weill Medical College of Cornell University
First received: March 8, 2010
Last updated: December 18, 2012
Last verified: December 2012
A recent study by Plotkin et al. showed that bevacizumab (Avastin) treatment was followed by clinically meaningful hearing improvement, tumor-volume reduction, or both in some, but not all, patients with Vestibular Schwannoma (VS) who were at risk for complete hearing loss or brain-stem compression from growing VS. Because of the promising results in preliminary studies of Bevacizumab and because of significant experience with the safety of the dosages proposed in this study, this study will offer a safe treatment for patients with VS. Therefore, this phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS.
Drug: Bevacizumab (Avastin)
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Trial Of Super-Selective Intraarterial Cerebral Infusion Of Avastin (Bevacizumab) For Treatment Of Vestibular Schwannoma
Primary Outcome Measures:
- Maximum tolerated dose. [ Time Frame: 1 month post procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Composite overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Six-month progression-free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hearing response will be assessed in eligible patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
Drug: Bevacizumab (Avastin)
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab in Vestibular Schwannoma
This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS
Other Name: Avastin
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or female patients of >= 18 years of age.
- Patients with a documented diagnosis of unilateral or bilateral VS based on MRI and who have evidence of progressive vestibular schwannomas, and are considered poor candidates for surgery and radiation therapy or declined these treatments.
- Patients must have a Karnofsky performance status >=60% (or the equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of >= three months.
- No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for two weeks prior to treatment under this research protocol.
- Patients must have adequate hematologic reserve with WBC>=3000/mm3, absolute neutrophils >=1500/mm3 and platelets >=100,000/ mm3. Patients who are on Coumadin must have a platelet count of >=150,000/ mm3.
- Pre-enrollment chemistry parameters must show: bilirubin< 1.5X the institutional upper limit of normal (IUNL); AST or ALT< 2.5X IUNL and creatinine < 1.5X IUNL.
- Pre-enrollment coagulation parameters (PT and PTT) must be <1.5X the IUNL.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Previous treatment with Avastin®.
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring including MRI with gadolinium.
- Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during study treatment.
- Current or recent (within 10 days of Avastin) use of aspirin (> 325 mg/day), full dose (i.e., therapeutic dose) of oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed (e.g., warfarin (1 mg qd) for catheter prophylaxis, and prophylactic low molecular-weight heparin (i.e., enoxaparin [(40mg QD0]).
- History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding.
- Inadequately controlled hypertension (blood pressure: systolic > 150 mmHg and/or diastolic > 100 mmHg).
- Patients with baseline urine dipstick for proteinuria > 2+ must undergo a 24-hours urine collection and must demonstrate ≤ 1 g of protein in 24 hours.
- Clinically significant (i.e., active) cardiovascular disease (e.g., cerebrovascular accident or myocardial infarction within 6 months prior to randomization),unstable angina, congestive heart failure (NYHA Class ≥ II), or serious cardiac arrhythmia that is uncontrolled by medication or may interfere with administration of study treatment.
- Serious non-healing sound, active peptic ulcer, or untreated bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
- Known hypersensitivity to Avastin or any of its excipients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083966
|Weill Cornell Medical College- NewYork Presbyteryan Hospital
|New York, New York, United States, 10065 |
|Contact: John Boockvar, MD 212-746-1996 email@example.com |
|Principal Investigator: John Boockvar, MD |
|Sub-Investigator: Susan C. Pannullo, MD |
|Sub-Investigator: Ronald Scheff, MD |
|Sub-Investigator: Robert Zimmerman, MD |
|Sub-Investigator: John A. Tsiouris, MD |
|Sub-Investigator: Ehud Lavi, MD |
|Weill Cornell Medical College
|New York, New York, United States, 10065 |
Weill Medical College of Cornell University
||John Boockvar, MD
||Weill Medical College of Cornell University
No publications provided
||John A. Boockvar, Associate Professor of Neurological Surgery, Weill Medical College of Cornell University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 8, 2010
||December 18, 2012
||United States: Institutional Review Board
Keywords provided by Weill Medical College of Cornell University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neoplasms by Site
Cranial Nerve Neoplasms
Vestibulocochlear Nerve Diseases
Cranial Nerve Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs