Clinical trial · Interventional
Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma
Phase I Study to Assess the Histologic Effect and Safety of Pre-Operative and Post-Operative Infusions of IL13-PE38QQR Cytotoxin in Patients With Recurrent Resectable Supratentorial Malignant Glioma
NCT00036972CI-TRIAL-00011109completedPhase 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: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma. PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy before and after surgery in treating patients who have recurrent malignant glioma.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cintredekin besudotox | Biological | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial malignant glioma (grade 3 or 4) * Anaplastic astrocytoma * Glioblastoma multiforme * Mixed oligoastrocytoma * Malignant astrocytoma, not otherwise specified * Prior first resection of brain tumor * Prior cranial radiotherapy with tumor dose of at least 48 Gy * Radiographic evidence of recurrent or progressive supratentorial tumor * In patients who have received external beam radiotherapy or localized radiotherapy (e.g., gamma-knife or brachytherapy) within the past 12 weeks, progression must be confirmed by metabolic imaging (magnetic resonance spectroscopy or positron-emission tomography) * Must be a candidate for second resection * No signs of impending herniation * No midline shift greater than 1 cm * No multifocal disease or subependymal tumor spread PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * PT and PTT no greater than upper limit of normal Renal: * Not specified Other: * No uncontrolled seizures * No other neurologic condition that would interfere with study evaluation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 60 days after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior cytotoxic therapy (2 weeks for vincristine or 6 weeks for nitrosoureas) Endocrine therapy: * Concurrent steroids allowed * No tapering of steroids during or immediately after study infusion Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * At least 4 weeks since prior investigational agents * At least 2 weeks since prior non-cytotoxic agents * No other concurrent antitumor therapy
References
Publications (1)
- BACKGROUNDKunwar S, Prados MD, Chang SM, Berger MS, Lang FF, Piepmeier JM, Sampson JH, Ram Z, Gutin PH, Gibbons RD, Aldape KD, Croteau DJ, Sherman JW, Puri RK; Cintredekin Besudotox Intraparenchymal Study Group. Direct intracerebral delivery of cintredekin besudotox (IL13-PE38QQR) in recurrent malignant glioma: a report by the Cintredekin Besudotox Intraparenchymal Study Group. J Clin Oncol. 2007 Mar 1;25(7):837-44. doi: 10.1200/JCO.2006.08.1117. PMID 17327604