Intraarterial Cerebral Infusion of Avastin for Vestibular Schwannoma (Acoustic Neuroma)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
John A. Boockvar, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01083966
First received: March 8, 2010
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Vestibular Schwannoma
Drug: Bevacizumab (Avastin)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial Of Super-Selective Intraarterial Cerebral Infusion Of Avastin (Bevacizumab) For Treatment Of Vestibular Schwannoma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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: 30
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin
IA Avastin
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083966

Contacts
Contact: John Boockvar, MD 212-746-1996 jab2029@med.cornell.edu
Contact: Tamika Wong, MPH 212-746-1788 taw2015@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Weill Cornell Medical College- NewYork Presbyteryan Hospital Not yet recruiting
New York, New York, United States, 10065
Contact: John Boockvar, MD    212-746-1996    jab2029@med.cornell.edu   
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         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: John Boockvar, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: John A. Boockvar, Associate Professor of Neurological Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01083966     History of Changes
Other Study ID Numbers: 0912010765
Study First Received: March 8, 2010
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Vestibular
Schwannoma
earing-loss
brain-tumor
Acoustic
Neuroma

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Ear Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroendocrine Tumors
Neuroma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Peripheral Nervous System Neoplasms
Retrocochlear Diseases
Vestibulocochlear Nerve Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014