Clinical trial · Interventional
Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma Anaplastic Foci | — | UNRESOLVED | — |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAB-425 radiolabeled with I-125 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated with MAB-425
- description
- All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
- interventionNames
- Drug: MAB-425 radiolabeled with I-125
Primary outcomes (1)
- measure
- Prevention of disease progression
- timeFrame
- 3 months after first course with follow-up
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available