Clinical trial · Interventional
Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas
Phase I/II Trial Of Intracerebral IL13-PE38QQR Infusions In Pediatric Patients With Recurrent Malignant Glioma
NCT00053040CI-TRIAL-00003963withdrawnPhase 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
Why stopped (as posted): Withdrawal of pharmaceutical company support for the investigational drug
Summary
Brief summary (as posted)
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of immunotoxin therapy and to see how well it works in treating children undergoing surgery for recurrent or progressive 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 | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cintredekin besudotox | Biological | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery for tumor resection + IL13-PE38QQR infusion
- interventionNames
- Biological: cintredekin besudotox
- Procedure: conventional surgery
Primary outcomes (4)
- measure
- Toxicities from the start of infusion through the dose limiting toxicity observation period(Phase I)
- timeFrame
- Start of IL13-PE38QQR infusion to Day 35 or Day 75
- description
- Toxicities reported are those occurring from the start of the IL13 infusion after catheter placement to Day 35 (30 days after the end of the infusion) if there are no or mild MRI changes on Day 35 around the catheter tract or tip. If the MRI change on Day 35 indicates moderate or extensive changes around the catheter tract or tip then the toxicities reported are those occurring from the start of the IL13 infusion to Day 75 (70 days after the end of the infusion).
- measure
- Maximum safe flow rate (Phase I)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed grade 3 or 4 supratentorial malignant glioma by prior surgery or biopsy * Anaplastic astrocytoma * Glioblastoma multiforme * Malignant mixed oligoastrocytoma * Recurrent or progressive disease by radiology * In first progression or recurrence (for patients in the phase II portion of the study only) * Must have 1 solid primary lesion with a solid component measuring at least 1 cm in diameter * Must have received external beam radiotherapy with tumor dose of at least 48 Gy * Planning to undergo gross total resection of the tumor to remove all contrast-enhancing components of the tumor * No multifocal tumor not amenable to gross tumor resection * No contrast-enhancing tumor component crossing the midline * No subependymal or leptomeningeal tumor dissemination * No clinically significant increased intracranial pressure (e.g., impending herniation) * No spinal cord compression * No requirement for immediate palliative treatment PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Karnofsky 60-100% (over 16 years of age) * Lansky 60-100 (16 years of age and under) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 10 g/dL\* * Platelet count at least 100,000/mm\^3\* NOTE: \*Transfusion independent Hepatic * PT and PTT normal Renal * Creatinine normal for age Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled seizures PRIOR CONCURRENT THERAPY: Biologic therapy * At least 8 weeks since prior hematopoietic stem cell transplantation Chemotherapy * No prior intracerebral chemotherapy for malignant glioma (except polifeprosan 20 with carmustine implant) * At least 6 months since prior polifeprosan 20 with carmustine implant * At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas) * At least 2 weeks since prior vincristine or noncytotoxic chemotherapy * No concurrent chemotherapy Endocrine therapy * Concurrent steroids allowed Radiotherapy * See Disease Characteristics * At least 8 weeks since prior radiotherapy * No prior focal radiotherapy for malignant glioma (e.g., single-fraction stereotaxic radiotherapy or brachytherapy) * Prior stereotactic radiosurgery boost as part of the initial fractionated external beam radiotherapy regimen allowed Surgery * See Disease Characteristics Other * Recovered from prior therapy * No prior investigational intracerebral agents * At least 4 weeks since prior systemic investigational agents * No prior localized antitumor therapy for malignant glioma * No concurrent anticoagulants or antiplatelet therapy, including, but not limited to, any of the following: * Heparin * Fractionated heparin * Warfarin * Aspirin * Ticlopidine * Clopidogrel * Dipyridamole * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.