Clinical trial · Interventional
Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors
Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin, Cyclophosphamide, and Etoposide Phosphate BBBD, in Children With Malignant Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): OHSU IRB closed study to further enrollment 2/17/2006
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, etoposide phosphate, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Mannitol may help chemotherapy work better by making it easier for these drugs to get to the tumor. Chemoprotective drugs, such as acetylcysteine and sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. Giving acetylcysteine together with mannitol, combination chemotherapy, and sodium thiosulfate may be an effective treatment for malignant brain tumors. PURPOSE: This phase I trial is studying the side effects and best dose of acetylcysteine when given together with mannitol, combination chemotherapy, and sodium thiosulfate in treating children with malignant brain tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Suppression | — | UNRESOLVED | — |
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylcysteine | Drug | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| mannitol | Drug | — | UNRESOLVED |
| sodium thiosulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess toxicity and the maximally tolerated dose of N-acetylcysteine administered in conjunction with carboplatin, cyclophosphamide and etoposide phosphate BBBD, and delayed high dose sodium thiosulfate, in children with malignant brain tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed brain tumors, including any of the following: * Brain stem glioma * Primitive neuroectodermal tumor * CNS germ cell tumor * Malignant glioma * Diagnosis based on any of the following: * CT-assisted or stereotactic biopsy * Open biopsy * Surgical resection * Cerebrospinal fluid cytology * Elevated tumor markers * Unequivocal radiographic changes (for patients with brain stem glioma or optic glioma) * All tumor types, except brain stem glioma, must be recurrent * No radiographic signs of intracranial herniation and/or spinal cord block PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * At least 90 days Hematopoietic * WBC ≥ 2,500/mm\^3 * Absolute granulocyte count ≥ 1,200/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGOT and SGPT \< 2.5 times upper limit of normal * Bilirubin \< 2.0 mg/dL Renal * Creatinine \< 1.8 mg/dL Pulmonary * No history of clinically significant reactive airway disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant risk for general anesthesia * No uncontrolled, clinically significant, confounding medical condition within the past 30 days * No contraindication to study drugs PRIOR CONCURRENT THERAPY: Chemotherapy * At least 28 days since prior systemic chemotherapy Radiotherapy * At least 3 months since prior total spine radiotherapy * At least 14 days since prior cranial radiotherapy * Prior systemic radiotherapy allowed Surgery * See Disease Characteristics
References
Publications (0)
Data not yet available