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

Study 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01317888
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Drexel University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme, Astrocytoma Anaplastic Foci
Arms & Interventions

Arms

Experimental: Treated with MAB-425

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

Interventions

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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