Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
NCT00002752CI-TRIAL-00015110completedPhase 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: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.
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 | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iodine I 131 monoclonal antibody 81C6 | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven primary or metastatic malignant supratentorial anaplastic glioma * Newly diagnosed or recurrent * No diffusely infiltrating or multifocal tumor * No tumor with subependymal spread * Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study * Measurable lesion on enhanced CT scan or MRI * No measurable enhancing lesion greater than 1.0 cm beyond cavity margin * Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody PATIENT CHARACTERISTICS: Age: * 3 and over Performance status: * Karnofsky 50-100% Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * AST less than 1.5 times normal * Alkaline phosphatase less than 1.5 times normal Renal: * Creatinine less than 1.2 mg/dL Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progression Endocrine therapy: * Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry Radiotherapy: * At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.