Clinical trial · Interventional
Oxaliplatin in Treating Children With Advanced Solid Tumors
A Phase I Study of Oxaliplatin in Children With Solid Tumors
NCT00005844CI-TRIAL-00008317completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.
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 |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or unresectable solid tumors that are not amenable to standard treatment * Histological confirmation not required for brain stem tumors * No known brain metastases * No leukemia PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * ECOG 0-2 OR * Lansky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 (except with marrow involvement) * Hemoglobin at least 8 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin 0.2-1.4 mg/dL * AST/ALT no greater than 3 times upper limit of normal Renal: * Creatinine normal for age OR * Creatinine clearance at least 50 mL/min * Electrolytes, calcium, and phosphorus normal Cardiovascular: * No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No active graft-vs-host disease (GVHD) * No allergy to platinum compounds or antiemetics * No uncontrolled concurrent illness or infection * No evidence of neuropathy * Blood sugar normal PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior hematopoietic growth factors * At least 3 months since prior stem cell transplantation and recovered Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea) Endocrine therapy: * Not specified Radiotherapy: * At least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment * At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and Y-port radiotherapy * At least 6 months since prior total body irradiation Surgery: * Not specified Other: * No concurrent therapy for GVHD * No other concurrent anticancer investigational or commercial agents * No other concurrent anticancer therapy
References
Publications (3)
- RESULTSpunt SL, Freeman BB 3rd, Billups CA, McPherson V, Khan RB, Pratt CB, Stewart CF. Phase I clinical trial of oxaliplatin in children and adolescents with refractory solid tumors. J Clin Oncol. 2007 Jun 1;25(16):2274-80. doi: 10.1200/JCO.2006.08.2388. PMID 17538173
- RESULTIacono LC, Spunt SL, Pratt CB, et al.: Pharmacokinetics of oxaliplatin in children with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2170, 89b, 2002.
- RESULTPratt CB, Spunt SL, Thompson SJ, et al.: Phase I Study of Oxaliplatin in Pediatric Patients with Malignant Solid Tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1498, 2001.