Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy
- 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: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| iodine I 131 monoclonal antibody 81C6 | Radiation | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| surgical procedure | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor * No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors * Candidate for surgical resection * Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required * Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Alkaline phosphatase less than 1.5 times normal * Lactic dehydrogenase less than 1.5 times normal * SGOT less than 1.5 times normal Renal: * Creatinine less than 1.2 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No iodine allergies PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics
References
Publications (0)
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