Oxaliplatin for Children With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina
ClinicalTrials.gov Identifier:
NCT01558453
First received: March 16, 2012
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
    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
Oxaliplatin
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).


  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01558453

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

No publications provided

Responsible Party: Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina
ClinicalTrials.gov Identifier: NCT01558453     History of Changes
Other Study ID Numbers: OXALI_L_04946
Study First Received: March 16, 2012
Last Updated: March 25, 2013
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Neoplasms
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014