Clinical trial · Interventional
Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma
Phase I Trial of GLIADEL and O(6)-Benzylguanine in Pediatric Patients With Recurrent Malignant Gliomas
NCT00045721CI-TRIAL-00002716terminatedPhase 1ClinicalTrials.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): Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy placed into the surrounding tissue after surgery to remove the tumor may kill any remaining tumor cells. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the safety of combining O(6)-benzylguanine with carmustine implants in treating children 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| polifeprosan 20 with carmustine implant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Biologically effective dose of O(6)-benzylguanine administered continuously in pediatric patients with recurrent malignant glioma
- measure
- Toxicities associated with the administration of O(6)-benzylguanine and carmustine implants.
Secondary outcomes (1)
- measure
- Tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed progressive supratentorial anaplastic astrocytoma or glioblastoma multiforme * No multifocal disease or leptomeningeal dissemination of tumor * No evidence of tumor crossing midline * Limited intraventricular involvement * Measurable unilateral mass at least 10 mm by contrast-enhanced MRI * Received prior involved-field radiotherapy as a component of prior therapy * Amenable to and in need of significant debulking PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Karnofsky 60-100% OR * Lansky 60-100% Life expectancy * More than 8 weeks Hematopoietic * Absolute neutrophil count greater than 1,000/mm3\* * Platelet count greater than 100,000/mm3\* * Hemoglobin greater than 8 g/dL (transfusions allowed) NOTE: \* Transfusion independent Hepatic * Bilirubin no greater than 1.5 times normal * AST and ALT less than 3 times normal * Albumin at least 2 g/dL * No overt hepatic disease Renal * Creatinine clearance no greater than 1.5 times normal OR * Glomerular filtration rate greater than 70 mL/min * No overt renal disease Cardiovascular * No overt cardiac disease Pulmonary * No overt pulmonary disease Other * Neurological deficits must be stable for at least the past week * No uncontrolled infection * No known hypersensitivity to nitrosoureas or polyethylene glycol * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 6 months since prior bone marrow transplantation * More than 2 weeks since prior colony-stimulating growth factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) Chemotherapy * No more than 2 prior cytotoxic chemotherapy regimens * No more than 3 prior chemotherapy regimens total * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered * Prior systemic carmustine (or other nitrosourea) allowed provided patient did not experience non-hematopoietic grade III/IV toxicity Endocrine therapy * Concurrent dexamethasone allowed if on a stable dose for at least the past week Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy * No prior craniospinal irradiation for metastatic disease Surgery * See Disease Characteristics * Prior biopsy or cytoreductive surgery allowed Other * Concurrent anticonvulsants allowed * No other concurrent anticancer or investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.