Clinical trial · Interventional
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
NCT00091182CI-TRIAL-00010629completedPhase 2ClinicalTrials.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)
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (26)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Central Nervous System Germ Cell Tumor | Childhood Central Nervous System Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.85 |
| Childhood Hepatoblastoma | Childhood Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Hepatocellular Carcinoma | Childhood Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Childhood High-grade Cerebral Astrocytoma | — | UNRESOLVED | — |
| Childhood Low-grade Cerebral Astrocytoma | — | UNRESOLVED | — |
| Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Malignant Testicular Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 3 years
- description
- Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed\* solid tumor, including any of the following:
* Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)
* Osteosarcoma
* Rhabdomyosarcoma
* Neuroblastoma
* High-grade astrocytoma
* Low-grade astrocytoma
* Glioblastoma multiforme
* Ependymoma
* Hepatoblastoma
* Germ cell tumors of any site
* Rare tumors of interest, including any of the following:
* Soft tissue sarcoma
* Hepatocellular carcinoma
* Childhood/adolescent colorectal carcinoma
* Childhood/adolescent renal cell carcinoma
* Childhood/adolescent adrenocortical carcinoma
* Childhood/adolescent nasopharyngeal carcinoma
* Recurrent disease OR refractory to conventional therapy
* Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography
* Performance status - Karnofsky 50-100% (for patients over age 10)
* Performance status - Lansky 50-100% (for patients age 10 and under)
* At least 8 weeks
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 75,000/mm\^3\* (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL\* (RBC transfusions allowed)
* Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met
* Bilirubin ≤ 3 mg/dL
* Creatinine based on age as follows:
* ≤ .8 mg/dL (for patients age 5 and under)
* ≤ 1.0 mg/dL (for patients age 6 to 10)
* ≤ 1.2 mg/dL (for patients age 11 to 15)
* ≤1.5 mg/dL (for patients age 16 to 21)
* Creatinine clearance or radioisotope glomerular filtration rate \> 20 mL/min
* No uncontrolled seizure disorder
* No uncontrolled infection
* CNS toxicity ≤ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Recovered from prior immunotherapy
* At least 7 days since prior anticancer biologic therapy
* More than 1 week since prior growth factors
* At least 6 months since prior allogeneic stem cell transplantation
* No evidence of active graft-vs-host disease
* No concurrent immunomodulating agents
* Recovered from prior chemotherapy
* No prior oxaliplatin
* Prior carboplatin or cisplatin allowed
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* No other concurrent anticancer chemotherapy
* Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior craniospinal radiotherapy
* At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
* At least 6 weeks since other prior substantial radiotherapy to the bone marrow
* Concurrent radiotherapy to localized painful lesions allowed provided ≥ 1 measurable lesion is not irradiated
* No other concurrent investigational agents
* No other concurrent anticancer agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.