search
Back to results

Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

Primary Purpose

Glioblastoma Multiforme, Astrocytoma Anaplastic Foci

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MAB-425 radiolabeled with I-125
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring high grade gliomas of the brain, anti-body treatment, survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 Years or Older
  • Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
  • Karnofsky performance status > 70%
  • Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL
  • Signed informed consent
  • Pathologic confirmation of GBM or AAF
  • A negative beta hCG test for women of childbearing potential
  • Negative HAMA test

Exclusion Criteria:

  • Metastases or Second Primary Cancer
  • Iodine allergy
  • Inability to tolerate oral intake of Lugol's solution
  • HIV Infection
  • Positive HAMA test
  • Pregnancy
  • Uncontrolled Seizures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treated with MAB-425

    Arm Description

    All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.

    Outcomes

    Primary Outcome Measures

    Prevention of disease progression
    For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2011
    Last Updated
    March 16, 2011
    Sponsor
    Drexel University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01317888
    Brief Title
    Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
    Official Title
    An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Drexel University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma Multiforme, Astrocytoma Anaplastic Foci
    Keywords
    high grade gliomas of the brain, anti-body treatment, survival

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    11 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treated with MAB-425
    Arm Type
    Experimental
    Arm Description
    All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
    Intervention Type
    Drug
    Intervention Name(s)
    MAB-425 radiolabeled with I-125
    Intervention Description
    MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.
    Primary Outcome Measure Information:
    Title
    Prevention of disease progression
    Description
    For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline
    Time Frame
    3 months after first course with follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 Years or Older Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions) Karnofsky performance status > 70% Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL Signed informed consent Pathologic confirmation of GBM or AAF A negative beta hCG test for women of childbearing potential Negative HAMA test Exclusion Criteria: Metastases or Second Primary Cancer Iodine allergy Inability to tolerate oral intake of Lugol's solution HIV Infection Positive HAMA test Pregnancy Uncontrolled Seizures

    12. IPD Sharing Statement

    Learn more about this trial

    Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

    We'll reach out to this number within 24 hrs