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Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
This study has been completed.
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091182
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

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.


Condition Intervention Phase
Adrenocortical Carcinoma
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Colorectal Cancer
Extragonadal Germ Cell Tumor
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Neuroblastoma
Ovarian Cancer
Sarcoma
Drug: oxaliplatin
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer Head and Neck Cancer Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma
Drug Information available for: Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Cumulative toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Correlation of the extent of drug exposure with response [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2004
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.
  • Determine the cumulative toxicity of this drug in these patients.
  • Determine the pharmacokinetic profile of this drug in these patients.
  • Determine time to progression and overall survival of patients treated with this drug.
  • 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.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 NOTE: *Histologic confirmation not required for brain stem tumors and visual pathway gliomas
  • Recurrent disease OR refractory to conventional therapy
  • Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography

PATIENT CHARACTERISTICS:

Age

  • 21 and under at original diagnosis

Performance status

  • Karnofsky 50-100% (for patients over age 10) OR
  • Lansky 50-100% (for patients age 10 and under)

Life expectancy

  • At least 8 weeks

Hematopoietic

  • 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 NOTE: *For patients without bone marrow involvement, including patients who underwent SCT

Hepatic

  • Bilirubin ≤ 3 mg/dL

Renal

  • 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) OR
  • Creatinine clearance or radioisotope glomerular filtration rate > 20 mL/min

Other

  • No uncontrolled seizure disorder
  • No uncontrolled infection
  • CNS toxicity ≤ grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • 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

Chemotherapy

  • 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

Endocrine therapy

  • Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry

Radiotherapy

  • 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

Surgery

  • Not specified

Other

  • No other concurrent investigational agents
  • No other concurrent anticancer agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091182

  Show 143 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Orren Beaty, DO, PhD Mission Children's Hospital
Investigator: Marcio A. Malogolowkin, MD Children's Hospital Los Angeles
Investigator: Stacey L. Berg, MD Texas Children's Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000384560, COG-ADVL0421
Study First Received: September 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00091182  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent osteosarcoma
recurrent childhood rhabdomyosarcoma
recurrent neuroblastoma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood cerebellar astrocytoma
recurrent childhood ependymoma
childhood hepatoblastoma
childhood extragonadal germ cell tumor
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
childhood teratoma
recurrent childhood malignant germ cell tumor
childhood central nervous system germ cell tumor
recurrent childhood soft tissue sarcoma
childhood hepatocellular carcinoma
recurrent childhood liver cancer
recurrent colon cancer
recurrent rectal cancer
recurrent renal cell cancer
recurrent adrenocortical carcinoma
recurrent nasopharyngeal cancer
recurrent childhood brain stem glioma
recurrent childhood visual pathway and hypothalamic glioma

Study placed in the following topic categories:
Liver Diseases
Neuroectodermal Tumors, Primitive
Rectal Neoplasms
Carcinoma, Hepatocellular
Adrenocortical carcinoma
Malignant mesenchymal tumor
Colonic Diseases
Adrenal Gland Diseases
Urogenital Neoplasms
Central Nervous System Neoplasms
Urologic Neoplasms
Osteogenic sarcoma
Rectal Diseases
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Neuroepithelioma
Adrenal Cortex Neoplasms
Glioma
Hepatoblastoma
Kidney Diseases
Rectal cancer
Nervous System Neoplasms
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Astrocytoma
Genital Neoplasms, Female
Endocrine System Diseases
Renal cancer
Testicular Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009