NCT00595322

Brief Summary

This is a pilot study. The goal of this study is to test whether Bevacizumab is safe enough in patients with brain tumors so that a larger study can be conducted. This study will also give us some information about whether the combination of Bevacizumab and radiation has potential to become an effective treatment for regrowing brain tumors. Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several different types of human cancer cells by blocking the effects of VEGF. There is also evidence that Bevacizumab enhances the effects of radiation on tumor cell

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

11.4 years

First QC Date

January 7, 2008

Last Update Submit

May 22, 2017

Conditions

Brain CancerRecurrent Malignant GliomasPrimary Brain Tumor

Keywords

BevacizumabRadiation TreatmentBrain Cancer

Outcome Measures

Primary Outcomes (1)

  • To test the safety of bevacizumab in patients with recurrent malignant gliomas in preparation for a larger study to test the efficacy of this drug used during the initial radiation treatment of these tumors if safety is affirmed.

    conclusion of study

Study Arms (1)

1

EXPERIMENTAL

bevacizumab and radiation (IMRT)

Other: bevacizumab and radiation (IMRT)

Interventions

bevacizumab and radiation (IMRT)OTHER

bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days). If the tumor volume remains \< 40 cc, the patient will undergo stereotactic radiotherapy with IMRT (30Gy) beginning anywhere from day 7-10 of cycle 2 (5 doses of 6 Gy over 2 and a half weeks)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent malignant glioma that has failed prior radiotherapy and/or chemotherapy. Surgery for the recurrence may be offered to selected patients prior to receiving bevacizumab and IMRT on this protocol.
  • MRI scan with gadolinium contrast showing geographically-circumscribed tumor \< than or equal to 3.5cm. (Scan must be performed on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between date of imaging and registration, a new baseline MRI is required).
  • Patients must have recovered from the toxic effects of prior therapy:
  • An interval of \> than or equal to 4 weeks (28 days) from prior cytotoxic therapy
  • An interval of \> than or equal to 1 week (7 days) from any non-cytotoxic agents
  • An interval of \> than or equal to 6 weeks (42 days) from the completion of radiation therapy
  • Absolute neutrophil count \> than or equal to 1,500/mm3.
  • Platelet count \> than or equal to 100,000/mm3.
  • Hemoglobin \> than or equal to 10 g/dl.
  • BUN and serum creatinine both \< 1.5 times upper limit of normal.
  • Total bilirubin both \< 1.5 times upper limit of normal.
  • SGOT and SGPT both \< than or equal to 3 times upper limit of normal.
  • Alkaline phosphatase \< than or equal to 2 times upper limit of normal.
  • \> than or equal to 18 years of age.
  • Karnofsky Performance Score \> or equal to 70
  • +3 more criteria

You may not qualify if:

  • 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.
  • Blood pressure \>150 mmHg systolic and/or \>100 mmHg diastolic
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • Unstable angina within 12 months of study enrollment
  • CTC 3.0 Grade 2 or greater congestive heart failure
  • History of myocardial infarction within 12 months of study enrollment
  • History of stroke or transient ischemic attack at any time
  • Known CNS disease
  • Known hypersensitivity to any component of bevacizumab
  • History of peptic ulcer within the last 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Use of ongoing anticoagulants or antiplatelet agents (aspirin, NSAIDS, etc)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of bevacizumab or anticipation of need for major surgical procedure during the course of the study. (Recently resected patients may be enrolled on-study two weeks post-surgery. However, treatment with Bevacizumab will not begin until 28 days after the surgical procedure for all patients.)
  • Craniotomy wound that has not sufficiently healed
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Gutin PH, Iwamoto FM, Beal K, Mohile NA, Karimi S, Hou BL, Lymberis S, Yamada Y, Chang J, Abrey LE. Safety and efficacy of bevacizumab with hypofractionated stereotactic irradiation for recurrent malignant gliomas. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):156-63. doi: 10.1016/j.ijrobp.2008.10.043. Epub 2009 Jan 23.

    PMID: 19167838DERIVED

Related Links

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Interventions

BevacizumabRadiation

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhysical Phenomena

Study Officials

  • Philip Gutin, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

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

January 7, 2008

First Posted

January 16, 2008

Study Start

December 1, 2005

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

US(2)