Completed

A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

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What is being tested

oxaliplatin

Drug
Who is being recruted

Nasopharyngeal Carcinoma+61

+ Urogenital Diseases

+ Genital Diseases

Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin. II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug. V. Correlate the extent of oxaliplatin exposure with response in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease type. 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.

Official TitleA Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors 
NCT00091182
Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nasopharyngeal CarcinomaUrogenital DiseasesGenital DiseasesAdenocarcinomaAdrenal Cortex DiseasesAdrenal Cortex NeoplasmsAdrenal Gland DiseasesAdrenal Gland NeoplasmsAstrocytomaCarcinomaCarcinoma, Renal CellEndocrine System DiseasesEndocrine Gland NeoplasmsEpendymomaFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleGenital Neoplasms, MaleGlioblastomaGliomaGonadal DisordersHead and Neck NeoplasmsKidney DiseasesKidney NeoplasmsStomatognathic DiseasesMyosarcomaNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Muscle TissueNeoplasms, Nerve TissueNeuroblastomaOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPathologic ProcessesPharyngeal DiseasesPharyngeal NeoplasmsRecurrenceRhabdomyosarcomaSarcomaSarcoma, EwingOsteosarcomaTeratomaTesticular DiseasesTesticular NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsNeuroectodermal TumorsNeoplasms, Complex and MixedHepatoblastomaNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveAdrenocortical CarcinomaNeoplasms, NeuroepithelialDisease AttributesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

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 agents

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Children's Oncology Group

Arcadia, United StatesSee the location
CompletedOne Study Center