Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Childhood Central Nervous System Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Hepatoblastoma, Childhood Hepatocellular Carcinoma, Childhood High-grade Cerebral Astrocytoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor, Childhood Teratoma, Recurrent Adrenocortical Carcinoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Colon Cancer, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Nasopharyngeal Cancer, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Rectal Cancer, Recurrent Renal Cell Cancer

Intervention / Treatment
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* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: oxaliplatin<br>* Given IV<br>* Other names: L-OHP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien. | Up to 3 years |