Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors
NCT00003478CI-TRIAL-00009514completedPhase 1 / Phase 2ClinicalTrials.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: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: This randomized phase I/II trial is studying the side effects, best way to give, and best dose of radiolabeled monoclonal antibody and to see how well it works in treating patients with primary brain tumors.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| iodine I 131 monoclonal antibody 81C6 | Radiation | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven newly diagnosed or recurrent primary intracranial WHO grade III or IV glioma * Reactivity of tumor cells with 81C6 demonstrated by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody * Radiographic evidence of a single lesion by MRI or CT scan * No greater than 2 to 5 cm * No cerebral herniation syndrome * Midline brain shift less than 0.5 cm PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin less than 1.5 mg/dL * Alkaline phosphatase less than 1.5 times normal * SGOT less than 1.5 times normal Renal: * Creatinine less than 2.0 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No allergies to iodine or local anesthetics PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent autologous bone marrow transplant Chemotherapy: * No more than 1 prior conventional or phase II chemotherapy regimen * No prior phase I chemotherapy regimens * At least 4 weeks since prior chemotherapy * No concurrent systemic chemotherapy Endocrine therapy: * Corticosteroids allowed but must be on stable dose for at least 1 week Radiotherapy: * At least 3 months since radiotherapy to site of measurable disease in the nervous system, unless evidence of progression Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.