A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
oxaliplatin
Nasopharyngeal Carcinoma+61
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.180 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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