Clinical trial · Interventional
TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
A Phase I/II Study Of A Recombinant Chimeric Protein Composed Of Transforming Growth Factor (TGF)-a And A Mutated Pseudomonas Exotoxin Termed PE38 (TP-38) In Pediatric Patients With Recurrent Or Progressive Supratentorial High Grade Gliomas
NCT00074334CI-TRIAL-00002728terminatedPhase 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): Drug company withdrawal of support for investigational agent in this indication.
Summary
Brief summary (as posted)
RATIONALE: The TP-38 toxin can locate tumor cells and kill them without harming normal cells. Giving TP-38 toxin directly into the tumor may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of TP-38 toxin administered directly into the brain and to see how well it works in treating young patients with recurrent or progressive supratentorial high-grade 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| TGFa-PE38 immunotoxin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Maximum safe volume rate of TP-38 infused through three catheters (Stratum A) or through two catheters (Stratum B).
- measure
- Maximum tolerated infusion concentration of TP-38 infused through three catheters (Stratum A) or through two catheters (Stratum B).
- measure
- Toxicities of TP-38
- measure
- Post-infusion survival (phase II)
Secondary outcomes (4)
- measure
- EGFR expression and phosphorylation (activity)
- measure
- Correlation of EGFR expression with tumor histology, tumor grade, tumor response (phase I and phase II) and survival and progression-free survival (phase II).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed supratentorial malignant glioma
* Recurrent or progressive disease
* Amenable to gross total resection, clinically indicated partial resection, or biopsy
* Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter
* No tumor crossing midline
* Tumors invading the corpus callosum that do not extend beyond to midline or into the contralateral hemisphere allowed
* No more than 1 focus of tumor
* No tumors involving the brainstem or cerebellum
* No tumor dissemination (i.e., subependymal or leptomeningeal)
* Must be on steroids ≥ 3 days prior to surgery
* Must have received prior external beam radiotherapy (tumor dose at least 45 Gy) and completed therapy at least 8 weeks before study entry
* No impending herniation, including midline shift greater than 0.5 cm
* No requirement for immediate palliative treatment
PATIENT CHARACTERISTICS:
Age
* 3 to 21
Performance status
* Karnofsky 60-100% (patients over 16 years of age) OR
* Lansky 60-100% (patients age 16 and under)
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\* NOTE: \*Transfusion independent
Hepatic
* ALT and AST less than 2.5 times upper limit of normal (ULN)
* PT and PTT no greater than ULN
Renal
* Creatinine less than 1.5 times normal OR
* Glomerular filtration rate greater than 70 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 30 days after study participation
* No uncontrolled seizures
* No active infection requiring treatment
* No unexplained febrile illness
* No known or suspected allergies to local anesthetics
* No systemic disease or other condition that may be associated with unacceptable anesthetic/operative risk and/or that would preclude study completion
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 8 weeks since prior hematopoietic stem cell transplantation
Chemotherapy
* At least 6 months since prior polifeprosan 20 with carmustine implant (Gliadel® wafer)
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and 2 weeks for vincristine)
* At least 2 weeks since prior non-cytotoxic chemotherapy
* No other prior intracerebral chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Concurrent steroids allowed
Radiotherapy
* See Disease Characteristics
* No prior focal radiotherapy (e.g., gamma knife radiosurgery, stereotactic radiosurgery, or brachytherapy)
* No concurrent radiotherapy
Surgery
* Not specified
Other
* Recovered from prior therapy
* At least 4 weeks since prior anticancer investigational agents
* No prior localized antitumor therapy for malignant glioma
* No other concurrent investigational agent
* No other concurrent anticancer (including alternative anticancer medicines/treatment) agent or therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.