The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors

NCT01201850 | Terminated Results

• 1 other identifier: 10-0418.cc
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to learn about the safety of the study drug bevacizumab(Avastin®), when used to treat radiation necrosis. The primary objective of this study is to test the feasibility of treating Central Nervous System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2 weeks. The secondary objectives of this study are:

• To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed by clinical evaluation;
• To investigate the neuro-imaging changes in radiation necrosis associated edema, including Mass Resonance (MR) spectroscopy;
• To evaluate changes in corticosteroid use in patients with radiation necrosis following treatment with bevacizumab;
• To evaluate changes in quality of life.

Conditions

Radiation Necrosis

Keywords

radiation necrosis; Bevacizumab (Avastin®); Central Nervous System Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received at Least 5 of the 6 Scheduled Doses of Bevacizumab

  This pilot study was designed to evaluate the feasibility of treating pediatric patients with CNS radiation necrosis with bevacizumab. Patients enrolled on study were assessed for number of doses of bevacizumab that they received while on study. Participants who successfully received at least 5 of the 6 planned doses of bevacizumab (IV every 2 weeks) without significant events were determined to have met the outcome measure.

  13 weeks

Secondary Outcomes (4)

• Neurologic Status With Bevacizumab Treatment

  13 weeks

• Corticosteroid Usage With Bevacixumab Treatment

  13 weeks

• Changes in Quality of Life With Bevacizumab Treatment

  13 weeks

• Number of Patients With Changes in Neuro-Imaging With Bevacizumab Treatment

  13 weeks

Study Arms (1)

Bevacizumab (Avastin®)

EXPERIMENTAL

Once enrolled on study, patients will be treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses.

Drug: Bevacizumab (Avastin®)

Interventions

Bevacizumab (Avastin®) DRUG

Once enrolled on study, patients will be treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses. An MRI will be done after the first cycle (3 doses/ 6weeks) and then again at the end of therapy.

Bevacizumab (Avastin®)

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥ 1 and \< 25 years of age at diagnosis
• Interval from radiation therapy at least 4 weeks and no more than 1 year
• Neurologic deterioration (long tract signs, cranial nerve signs or ataxia) consistent with radiation necrosis
• MRI imaging with findings consistent with radiation necrosis as confirmed by the study radiologist
• Craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of study entry
• More than 28 days elapsed from the last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity)
• Lansky or Karnofsky performance \> 40%
• Patients may be on steroids at study entry
• Adequate organ function defined as:
• Peripheral absolute neutrophil (ANC) \>/= 1000/units/Liter(uL)
• Platelet count \>/= 50,000/uL
• Hemoglobin \>/= 9.0 gm/dL (transfusion permitted)
• Adequate Coagulation function defined as:
• Prothrombin Time (PT)/activated Partial Thromboplastin Time (aPTT) \</= 1.5x institutional upper limit of normal (ULN) for age;
• Adequate Renal Function defined as:

You may not qualify if:

• Evidence of recent (less than 2 weeks) hemorrhage on postoperative MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumour are permitted entry into the study.
• Subjects meeting any of the following criteria are ineligible for study entry:
• Inability to comply with study and/or follow-up procedures
• Life expectancy of less than 12 weeks
• Patients who have had chemotherapy within three (3) weeks or radiation within four (4) weeks. Patients may not receive additional chemotherapeutic agents while on this study.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Active second malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years.
• Inadequately controlled hypertension (defined as above the normal published range for age and height)
• 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 12 months prior to Day 1
• No history of stroke or transient ischemic attack
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1; History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
• 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 Day 1 or anticipation of need for major surgical procedure during the course of the study

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Margaret Macy, MD
• Organization: Children's Hospital Colorado

margaret.macy@childrenscolorado.org

720-777-5877

Study Officials

• Margaret Macy, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 15, 2010
• Study Start: June 28, 2010
• Primary Completion: August 4, 2016
• Study Completion: August 4, 2016
• Last Updated: May 19, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Locations

US (1)