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

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ClinicalTrials.gov Identifier: NCT01317888
Recruitment Status : Unknown
Verified January 2011 by Drexel University.
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:
Drexel University

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).

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Astrocytoma Anaplastic Foci Drug: MAB-425 radiolabeled with I-125 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2010
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treated with MAB-425
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
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.




Primary Outcome Measures :
  1. Prevention of disease progression [ Time Frame: 3 months after first course with follow-up ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Luther W. Brady, M.D., Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT01317888     History of Changes
Other Study ID Numbers: 18508
1043323 ( Other Identifier: Drexel University College of Medicine IRB )
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: January 2011

Keywords provided by Drexel University:
high grade gliomas of the brain
anti-body treatment
survival

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue