Clinical trial · Interventional
Chemotherapy in Treating Children With Neuroblastoma
PILOT STUDY OF BUTHIONINE SULFOXIMINE (BSO) IN COMBINATION WITH MELPHALAN FOR HIGH RISK NEUROBLASTOMA PATIENTS
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining buthionine sulfoximine with chemotherapy may reduce resistance to the drug and allow more tumor cells to be killed. PURPOSE: Phase I trial to study the effectiveness of melphalan, buthionine sulfoximine, and G-CSF in treating children with progressive neuroblastoma that has not responded to previous therapy.
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 |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| buthionine sulfoximine | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Neuroblastoma histologically confirmed at initial diagnosis or demonstration of malignant, small, round cell tumor with elevated catecholamine metabolites Refractory to conventional therapy and other higher priority therapy PATIENT CHARACTERISTICS: Age: No greater than 21 at diagnosis Performance status: 0-2 Life expectancy: At least 2 months Hematopoietic: Cytopenias from marrow involvement eligible with study chairman approval ANC at least 1,000 Platelets at least 100,000 (transfusion independent) Counts between 70,000-100,000 allowed provided: Autologous bone marrow or peripheral stem cells available for rescue Study chairman approves entry Hemoglobin at least 8 g/dL (may transfuse) Hepatic: Bilirubin no greater than 1.5 times normal AST/ALT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope GFR at least 70 mL/min per 1.73 square meters Pulmonary: No history of dyspnea at rest No exercise intolerance Other: No active infection requiring hospitalization No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients during and for 2 months after study Patients unable to receive blood products due to religious reasons may receive buthionine sulfoximine alone PRIOR CONCURRENT THERAPY: At least 6 months since myeloablative therapy with bone marrow transplantation Recovered from toxic effects of prior therapy Biologic therapy: Not specified Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since mitomycin or nitrosourea) Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy to any extremity site or significant marrow-containing compartment At least 6 months since the following: More than 24 Gy craniospinal irradiation Total abdominopelvic plus lung irradiation Mantle plus Y-port irradiation Total-body irradiation No palliative radiotherapy to bony lesions within 1 month after entry Surgery: Not specified
References
Publications (0)
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