Clinical trial · Interventional
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse
- 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)
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.
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 |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131I-chTNT-1/B MAb (Cotara) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 131I-chTNT-1/B MAb (Cotara)
- interventionNames
- Drug: 131I-chTNT-1/B MAb (Cotara)
Primary outcomes (1)
- measure
- To confirm the safety and tolerability of the maximum tolerated dose
Secondary outcomes (1)
- measure
- To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed GBM * Clinical Target Volume between 5 and 60 cc (inclusive) * 18 to 75 years old (inclusive) * Karnofsky Performance Status ≥ 70 percent * If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed * Adequate hematology * Adequate renal function * Adequate liver function Exclusion Criteria: * Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease * Bilateral non-contiguous gadolinium enhancing tumor * Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions) * Known or suspected allergy to study medication or iodine * Surgical procedure within four weeks of baseline * More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline * Radiation therapy within four weeks of baseline * Investigational agent within last 30 days * Previous treatment with any chimeric monoclonal antibody * HIV positive * Evidence of active hepatitis
References
Publications (0)
Data not yet available