Clinical trial · Interventional
Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma
Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
NCT00004017CI-TRIAL-00001996completedPhase 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 deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors. PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| iodine I 131 monoclonal antibody TNT-1/B | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA) * MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm\^3 * Recurrent GBM and AA must be documented by MRI after the most recent treatment and before any planned surgical debulking * At least 5 days since prior surgical debulking * No planned resection of newly diagnosed GBM before or during study * No bilateral noncontiguous gadolinium enhancing tumors * No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip * No more than 2 satellite lesions PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 Hepatic: * Hepatitis B surface antigen negative * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN * Lactic dehydrogenase no greater than 3 times ULN * Prothrombin time no greater than 1.5 times ULN Renal: * Creatinine clearance at least 50 mL/min Cardiovascular: * No significant unstable cardiovascular disease * No New York Heart Association class III/IV heart disease * No evidence of myocardial infarction within the past 3 months Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Human antichimeric antibody (HACA) titer no greater than 48 ng/mL * No anatomical or physiological considerations that would preclude study participation * No active autoimmune disease, active infection, or traumatic injury requiring treatment * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers Endocrine therapy: * Not specified Radiotherapy: * At least 8 weeks since prior external beam or gamma knife radiotherapy Surgery: * See Disease Characteristics Other: * At least 30 days since prior investigational treatment
References
Publications (0)
Data not yet available
No reference posted for this study.