Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
Not Applicable
- Conditions
- Glioblastoma MultiformeAstrocytoma Anaplastic Foci
- Interventions
- Drug: MAB-425 radiolabeled with I-125
- Registration Number
- NCT01317888
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 11
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated with MAB-425 MAB-425 radiolabeled with I-125 All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
- Primary Outcome Measures
Name Time Method Prevention of disease progression 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
- Secondary Outcome Measures
Name Time Method