Clinical trial · Interventional
Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme
Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
- 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)
RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131-I-chTNT-1/B MAB | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- 1.5 mCi/cc
- interventionNames
- Drug: 131-I-chTNT-1/B MAB
- type
- EXPERIMENTAL
- label
- 2
- description
- 2.0 mCi/cc
- interventionNames
- Drug: 131-I-chTNT-1/B MAB
- type
- EXPERIMENTAL
- label
- 3
- description
- 2.5 mCi/cc
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with recurrent GBM * Patients with a Clinical Target Volume between 5 and 60 cc (inclusive) * Patients of 18 years of age or older * Karnofsky Performance Status ≥ 60 at screening * Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry Exclusion Criteria: * Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm * Patients with diffuse disease * Patients with known or suspected allergy to study medication or iodine * Patients who received investigational agents within 30 days prior to baseline * Patients who received surgical resection within 4 weeks from baseline * Patients with known HIV or evidence of active hepatitis * Patients who cannot undergo MRI
References
Publications (0)
Data not yet available