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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00091182
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Orren Beaty
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm I

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.

Interventions

Drug: - oxaliplatin

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Oncology Group, Arcadia, California

Status

Address

Children's Oncology Group

Arcadia, California, 91006-3776

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