Clinical trial · Interventional
Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
NCT00052624CI-TRIAL-00032926unknownPhase 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 an effective treatment for glioblastoma multiforme and anaplastic astrocytoma. PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transferrin-CRM107 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the following tumor characteristics: * Unifocal * Unilateral and supratentorial * Diameter no greater than 3.5 cm by contrast-enhanced MRI * No more than 1 satellite tumor * Recurrent or progressive disease * Progressive disease defined as at least 25% increase in tumor volume by serial MRI or CT scans and/or at least 15% increase in the largest cross-sectional area of tumor as defined by the area of contrast agent enhancement * Must have received prior conventional treatment comprising both of the following: * Surgery (biopsy or debulking) * Radiation therapy * No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness, or clinically significant papilledema PATIENT CHARACTERISTICS: Age * 5 to 18 Performance status * Karnofsky 60-100% OR * Lansky Play 50-100% Life expectancy * At least 3 months Hematopoietic * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL * AST and ALT no greater than 2.5 times the upper limit of normal (ULN) * PT or aPTT no greater than 1.5 times ULN Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 months after study * No acute viral, bacterial, or fungal infection requiring therapy * Topical treatment for oral candidiasis allowed * No other concurrent medical condition that would preclude anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy * No prior transferrin-CRM107 Chemotherapy * More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * More than 3 months since prior biodegradable polymer wafers * No concurrent chemotherapy Endocrine therapy * Must be on stable dose of steroids for 7 days prior to infusion Radiotherapy * See Disease Characteristics * More than 3 months since prior radiotherapy * More than 3 months since prior stereotactic radiosurgery * More than 6 weeks since prior craniospinal irradiation * No prior brachytherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * More than 1 month since prior surgery including tumor surgery or debulking * No other concurrent surgery Other * More than 30 days since prior investigational agents * No other concurrent investigational therapy * No other concurrent anti-cancer drugs
References
Publications (0)
Data not yet available
No reference posted for this study.