Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Bevacizumab for Recurrent Malignant Glioma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent High-Grade Gliomas

Malignant Gliomas

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Background: Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progressio...

Detailed Description

Background * In vivo experiments have documented the ability of anti-vascular endothelial growth factor (VEGF) antibodies like bevacizumab to inhibit tumor growth in various preclinical tumor models,...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Patients with histologically proven intracranial malignant glioma will be eligible for this protocol.
  • Malignant glioma include glioblastoma multiforme (GBM),
  • gliosarcoma,
  • anaplastic astrocytoma (AA),
  • anaplastic oligodendroglioma (AO),
  • anaplastic mixed oligoastrocytoma (AMO),
  • or malignant astrocytoma NOS (not otherwise specified).
  • Patients must have evidence for tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
  • This scan should be performed within 14 days prior to registration and on a fixed dose of steroids for at least 5 days.
  • If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required.
  • The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.
  • Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
  • They have recovered from the effects of surgery.
  • Residual disease following resection of recurrent tumor is not mandated for eligibility into the study.
  • To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:
  • no later than 96 hours in the immediate post-operative period or
  • at least 4 weeks post-operatively, and
  • within 14 days of registration, and
  • on a steroid dosage that has been stable for at least 5 days.
  • If the 96 hour scan is more than 21 days before registration, the scan needs to be repeated.
  • If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days.
  • Patients must have progressed after radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
  • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
  • Patients must be greater than or equal to 18 years old,
  • and with a life expectancy greater than 8 weeks.
  • Patients must have a Karnofsky performance status of greater than or equal to 60.
  • Patients must have recovered from the toxic effects of prior therapy:
  • 2 weeks from any investigational agent,
  • 4 weeks from prior cytotoxic therapy,
  • two weeks from vincristine,
  • 6 weeks from nitrosoureas,
  • 3 weeks from procarbazine administration,
  • and 1 week for non-cytotoxic agents, e.g., interferon,
  • tamoxifen,
  • thalidomide,
  • cis-retinoic acid, etc. (radiosensitizer does not count).
  • Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
  • Patients must have adequate bone marrow function (white blood count (WBC) -greater than or equal to 3,000/microliters,
  • absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3,
  • platelet count of greater than or equal to 100,000/mm\^3,
  • and hemoglobin greater than or equal to 10 gm/dl),
  • adequate liver function (serum glutamic oxaloacetic transaminase (SGOT) and -bilirubin less than 2 times upper limit of normal (ULN)),
  • and adequate renal function (creatinine less than 1.5 mg/dL and/or creatinine -clearance greater than or equal to 60 cc/min) before starting therapy.
  • These tests must be performed within 14 days prior to registration. -Eligibility level for hemoglobin may be reached by transfusion.
  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy
  • This study was designed to include women and minorities, but was not designed to measure differences of intervention effects.
  • Males and females will be recruited with no preference to gender.
  • No exclusion to this study will be based on race.
  • Minorities will actively be recruited to participate.
  • Urine protein should be screened by dipstick or urine analysis for Urine Protein Creatinine (UPC) ratio.
  • For proteinuria greater than or equal to 1+ or urine protein:
  • creatinine UPC ratio greater than 1.0,
  • 24-hour urine protein should be obtained and the level should be less than 1000 mg for patient enrollment.
  • Patients must practice adequate contraception
  • EXCLUSION CRITERIA:
  • Patients who, in the view of the treating physician,
  • have significant active cardiac,
  • hepatic,
  • renal,
  • or psychiatric diseases are ineligible.
  • No concurrent use of other standard chemotherapeutics or investigative agents.
  • Patients known to have a malignancy that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except non-melanoma skin cancer or carcinoma in-situ in the cervix).
  • Patients who have an active infection.
  • Pregnant (positive pregnancy test) or nursing women.
  • Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy.
  • Patients who have any disease that will obscure toxicity.
  • Patients with evidence of acute intracranial/intratumoral hemorrhage on pre-study CT scan.
  • Concurrent anti-coagulation or anti-platelet medication (including aspirin, -non-steroidal anti-inflammatories,
  • cyclooxygenase 2 (COX-2) inhibitors).
  • Serious or non-healing wound,
  • ulcer
  • or bone fracture
  • History of abdominal fistula,
  • gastrointestinal perforation
  • or intra-abdominal abscess within 28 days
  • Invasive procedures defined as follows:
  • Major surgical procedure,
  • open biopsy
  • or significant traumatic injury within 28 days prior to Day 1 therapy
  • Anticipation of need for major surgical procedures during the course of the study
  • Core biopsy within 7 days prior to day 1 (D1) therapy
  • Patients with clinically significant cardiovascular disease
  • History of cerebrovascular accident (CVA) within 6 months
  • Uncontrolled hypertension (greater than 150/100 mmHg)
  • Myocardial infarction or unstable angina within 6 months
  • New York Heart Association grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Unstable angina pectoris
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Prothrombin time (PT) international normalized ratio (INR) greater than 1.5
  • Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2014

    Estimated Enrollment :

    88 Patients enrolled

    Trial Details

    Trial ID

    NCT00271609

    Start Date

    December 1 2005

    End Date

    February 1 2014

    Last Update

    April 29 2014

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892