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Trial record 8 of 1986 for:    oxaliplatin

Oxaliplatin for Children With Solid Tumors

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina

Tracking Information
First Submitted Date  ICMJE March 16, 2012
First Posted Date  ICMJE March 20, 2012
Last Update Posted Date March 26, 2013
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2012)
Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis. [ Time Frame: Up 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01558453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxaliplatin for Children With Solid Tumors
Official Title  ICMJE Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed Solid Tumor
  • Refractory Solid Tumor
Intervention  ICMJE 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).

Study Arms  ICMJE Experimental: Eloxatin
Oxaliplatin
Intervention: Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 19, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01558453
Other Study ID Numbers  ICMJE OXALI_L_04946
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidnei Epelman, Hospital Santa Marcelina
Study Sponsor  ICMJE Sidnei Epelman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sidnei Epelman, MD Santa Marcelina Hospital
PRS Account Hospital Santa Marcelina
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP