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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01317888
• Other study ID #: 18508
• Secondary ID: 1043323
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2011
• Last updated: March 16, 2011
• Start date: January 2010

Study information

• Verified date: January 2011
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Astrocytoma Anaplastic Foci
• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• MAB-425 radiolabeled with I-125
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after first course with follow-up	No