Clinical trial NCT01558453: Oxaliplatin for Children With Solid Tumors
Official title: Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed Solid Tumor
Refractory Solid Tumor
Lead sponsor: Hospital Santa Marcelina
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 20
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.
timeFrame: Up 2 years
Secondary outcomes:
measure: 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).
timeFrame: Up 2 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Santa Marcelina Hospital
state: SP
Study officials:
affiliation: Santa Marcelina Hospital
name: Sidnei Epelman, MD
role: STUDY_CHAIR
References: