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
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
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
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