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Oxaliplatin for Children With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558453
Recruitment Status : Unknown
Verified March 2013 by Sidnei Epelman, Hospital Santa Marcelina.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2012
Last Update Posted : March 26, 2013
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina

Brief Summary:
The purpose of this study is to determine the pediatric neoplastic response to chemotherapy proposed and evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.

Condition or disease Intervention/treatment Phase
Relapsed Solid Tumor Refractory Solid Tumor Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors
Study Start Date : March 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Eloxatin
Drug: Oxaliplatin

Oxaliplatin will be administered in a 130 mg/m² dose, 2 hour IV infusion, once every 3 weeks. Each cycle will last 3 weeks, or 21 days. Drug will be administered till progression disease or untolerable adverse event.

NOTE: patients with ≤ 12 months old will receive a 4,3 mg/kg dese (based on a 30 kg/m² conversion; i.e: in a 130 mg/m² dose, divided by 30).

Primary Outcome Measures :
  1. Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis. [ Time Frame: Up 2 years ]

Secondary Outcome Measures :
  1. Define cumulative toxicity after oxaliplatin multiple cycles in this population. Evaluate relation between time exposure to the drug (number of cycles) and response (antitumor effect x response). [ Time Frame: Up 2 years ]
    Determine response time and overall survival in these patients.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≤ 21 years old at the time of cancer diagnosis.
  2. Confirmed histological diagnosis - every patient, except brains tumor, or optic pathway glioma, should have one of the following histological diagnosis:

    • Ewing´s sarcoma/PNET
    • Osteosarcoma
    • Soft tissue sarcoma/rhabdomyosarcoma
    • Wilms tumor
    • Neuroblastoma
    • Retinoblastoma
    • Low grade astrocytoma
    • High grade astrocytoma/GBM
    • Ependymoma
    • Germ cell tumor Other rare tumors such as - hepatocellular carcinoma, pediatric colorectal carcinoma, renal cell carcinoma, adrenocortical carcinoma and nasopharyngeal carcinoma.
  3. All subjects should have measurable disease, at least in one dimension, 20mm minimum, or presence of neoplastic cell in cephalorachidian fluid.
  4. All patients must have a life expectancy ≥ 8 weeks, with PS Karnofsky ≥50 for patients with ≥ 10 years old and PS Lansky ≥50 for patients < 10 years old.
  5. Previous treatment:

    • at least 3 weeks without chemotherapy.
    • at least 6 months after spine and brain radiation.
    • it is allowed corticosteroids in patients with CNS tumor, but it is recommended to have stable doses or reducing the dose 7 days before protocol treatment.
    • there´s no limit of drugs or chemotherapy used previously, except oxaliplatin.
  6. Adequate function as define by:

    • Hematologic: neutrophil > 1000/mm³, platelet > 75000/mm³ and hemoglobin > 8 g/dL.
    • Renal - creatinine according to:

    Age ≤ 5 anos Cr ≤ 0,8 mg/dL 5 < age < 10 Cr ≤ 1,0 mg/dL 10 < age ≤ 15 Cr ≤ 1,2 mg/dL > 15 years Cr ≤ 1,5 mg/dL

    • Hepatic: total bilirubin ≤ 3 mg/dL.
    • Neurologic: patients should seizure control.
  7. Legal representative (father, mother or tutor) or subject (if >18 years old) must sign and date Informed Consent Form (ICF), after have being informed about relevant aspects regarding study participation.
  8. For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day 0.
  9. Patient must agree in use effective contraception if procreative potential exists. Use of reliable means of contraception (e.g. hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier, abstinence) for subjects of reproductive potential (males and females) is required during study treatment and for 3 months following last dose of study drug
  10. It should not have known curative treatment option and no proved therapy that increased survival with quality of life.

Exclusion Criteria:

  1. Oxaliplatin previous use.
  2. Another chemotherapy or experimental drug, simultaneously.
  3. If female, pregnant or lactating.
  4. Active infection.
  5. Any serious existent condition that could affect, in adverse way, subjet's capacity to be treat according to protocol.
  6. Any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives.
  7. Use of investigational drug < 30 days before entering study.
  8. Medical history with:

    • severe renal insufficiency;
    • known hypersensitiveness to platine;
    • myelosuppression;
    • peripheral sensory neuropathy.

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 identifier (NCT number): NCT01558453

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Santa Marcelina Hospital
Sao Paulo, SP, Brazil, 08270070
Sponsors and Collaborators
Sidnei Epelman
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Study Chair: Sidnei Epelman, MD Santa Marcelina Hospital

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Responsible Party: Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina Identifier: NCT01558453    
Other Study ID Numbers: OXALI_L_04946
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Antineoplastic Agents