Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Oxaliplatin for Children With Solid Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Hospital Santa Marcelina.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina Identifier:
First received: March 16, 2012
Last updated: March 25, 2013
Last verified: March 2013
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 Intervention Phase
Relapsed Solid Tumor
Refractory Solid Tumor
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors

Resource links provided by NLM:

Further study details as provided by Hospital Santa Marcelina:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


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.
  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 identifier: NCT01558453

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

Responsible Party: Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina Identifier: NCT01558453     History of Changes
Other Study ID Numbers: OXALI_L_04946
Study First Received: March 16, 2012
Last Updated: March 25, 2013

Additional relevant MeSH terms:
Antineoplastic Agents processed this record on April 25, 2017