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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloxatin | Experimental | Oxaliplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis. | Up 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Determine response time and overall survival in these patients. | Up 2 years |
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Inclusion Criteria:
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:
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.
Previous treatment:
Adequate function as define by:
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
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.
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sidnei Epelman, MD | Santa Marcelina Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Marcelina Hospital | São Paulo | São Paulo | 08270070 | Brazil |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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