Clinical trial · Interventional
Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse
NCT00128635CI-TRIAL-00020985completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (\^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme. PURPOSE: This phase I trial is studying the side effects and best dose of \^131I MOAB TNT-1/B in treating patients with progressive or 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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iodine I 131 monoclonal antibody TNT-1/B | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
Secondary outcomes (3)
- measure
- Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days
- measure
- Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks
- measure
- Overall survival, median time of survival, and percent alive at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Focal disease * Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy * Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed * Gross tumor volume 5-60 mL * No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles * No bilateral non-contiguous gadolinium-enhancing tumor * No diffuse disease, defined as any satellite lesion \> 1.5 cm from the anticipated location of a catheter tip OR \> 2 satellite lesions * No ventricular invasion outside the anticipated radiotherapy volume PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Hepatitis B negative * No evidence of active hepatitis Renal * Creatinine ≤ 1.7 mg/dL * BUN ≤ 2 times ULN Cardiovascular * No uncontrolled hypertension * No unstable angina pectoris * No uncontrolled cardiac dysrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to undergo MRI * Mini Mental State Exam score ≥ 15 * No serious infection * No other medical illness that would preclude study participation * No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer * No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance * No known or suspected allergy to study drug or iodine * No known HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy * No prior monoclonal antibodies * No prior local immunotherapy or treatment with the following biologic agents: * Immunotoxins * Immunoconjugates * Antiangiogenesis compounds * Antisense agents * Peptide receptor antagonist * Interferons * Interleukins * Tumor infiltrating lymphocytes * Lymphokine-activated killer cells * Gene therapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer\^® ) Endocrine therapy * Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entry Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy * No prior brachytherapy or radiosurgery Surgery * At least 4 weeks since prior surgery Other * Recovered from all prior therapy * At least 1 month since prior investigational agents * No more than 2 prior treatment regimens * No other prior local therapy
References
Publications (0)
Data not yet available
No reference posted for this study.