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Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors

Phase 2
21 Years
Open (Enrolling)
Relapsed Solid Tumor, Refractory Solid Tumor

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Trial Information

Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors

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

- 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.

Outcome Time Frame:

Up 2 years

Safety Issue:


Principal Investigator

Sidnei Epelman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Santa Marcelina Hospital


Brazil: Ethics Committee

Study ID:




Start Date:

March 2011

Completion Date:

December 2013

Related Keywords:

  • Relapsed Solid Tumor
  • Refractory Solid Tumor
  • Neoplasms