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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Drexel University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT01317888
First received: March 16, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention
Glioblastoma Multiforme
Astrocytoma Anaplastic Foci
Drug: MAB-425 radiolabeled with I-125

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Prevention of disease progression [ Time Frame: 3 months after first course with follow-up ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 11
Study Start Date: January 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: March 16, 2011
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014