Clinical trial · Interventional
Immunotoxin Therapy in Treating Patients With Malignant Glioma
Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
NCT00006268CI-TRIAL-00010951completedPhase 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: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cintredekin besudotox | Biological | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| isolated perfusion | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven malignant glioma (grade 3 or 4) * Anaplastic astrocytoma * Glioblastoma multiforme * Malignant mixed oligoastrocytoma * Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study * Must have undergone supratentorial brain tumor surgery or biopsy * Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study * Must have solid portion measuring 1.0-5.0 cm in maximum diameter * Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm * No tumor crossing the midline * No leptomeningeal tumor dissemination * No impending herniation or spinal cord compression * No uncontrolled seizures PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% 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 Hepatic: * PT and PTT no greater than upper limit of normal (ULN) * SGOT and SGPT no greater than 2.5 times ULN * Bilirubin no greater than 2.0 mg/dL Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior intralesional chemotherapy for malignant glioma * At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered * No concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study Radiotherapy: * See Disease Characteristics * No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma Surgery: * See Disease Characteristics Other: * Recovered from any prior therapy * No other concurrent investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.