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
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.
Relapsed Solid Tumor
Refractory Solid Tumor
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors
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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
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)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age ≤ 21 years old at the time of cancer diagnosis.
Confirmed histological diagnosis - every patient, except brains tumor, or optic pathway glioma, should have one of the following histological diagnosis:
- Ewing´s sarcoma/PNET
- Soft tissue sarcoma/rhabdomyosarcoma
- Wilms tumor
- Low grade astrocytoma
- High grade astrocytoma/GBM
- Germ cell tumor Other rare tumors such as - hepatocellular carcinoma, pediatric colorectal carcinoma, renal cell carcinoma, adrenocortical carcinoma and nasopharyngeal carcinoma.
- All subjects should have measurable disease, at least in one dimension, 20mm minimum, or presence of neoplastic cell in cephalorachidian fluid.
- 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.
- 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.
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.
- 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.
- For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day 0.
- 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
- It should not have known curative treatment option and no proved therapy that increased survival with quality of life.
- Oxaliplatin previous use.
- Another chemotherapy or experimental drug, simultaneously.
- If female, pregnant or lactating.
- Active infection.
- Any serious existent condition that could affect, in adverse way, subjet's capacity to be treat according to protocol.
- 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.
- Use of investigational drug < 30 days before entering study.
Medical history with:
- severe renal insufficiency;
- known hypersensitiveness to platine;
- peripheral sensory neuropathy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01558453
|Santa Marcelina Hospital
|Sao Paulo, SP, Brazil, 08270070 |
||Sidnei Epelman, MD
||Santa Marcelina Hospital
||Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 16, 2012
||March 25, 2013
||Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016