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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00091182
First received: September 7, 2004
Last updated: June 4, 2013
Last verified: June 2013
  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.


Condition Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.


Enrollment: 180
Study Start Date: October 2004
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091182

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Investigators
Principal Investigator: Orren Beaty Children's Oncology Group
  More Information

No publications provided

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
Study First Received: September 7, 2004
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014