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

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ClinicalTrials.gov Identifier: NCT00091182
Recruitment Status : Completed
First Posted : September 9, 2004
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: oxaliplatin Phase 2

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
Study Start Date : October 2004
Actual Primary Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 3 years ]
    Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091182


Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Orren Beaty Children's Oncology Group
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091182     History of Changes
Other Study ID Numbers: NCI-2012-01815
ADVL0421
COG-ADVL0421
CDR0000384560
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2004    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Sarcoma
Carcinoma, Hepatocellular
Glioma
Neuroblastoma
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Astrocytoma
Carcinoma, Renal Cell
Osteosarcoma
Rhabdomyosarcoma
Ependymoma
Sarcoma, Ewing
Germinoma
 Ovarian Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Testicular Neoplasms
Teratoma
Rhabdomyosarcoma, Embryonal
Nasopharyngeal Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Adrenocortical Carcinoma
Optic Nerve Glioma
Hepatoblastoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Adenocarcinoma