Oxaliplatin for Children With Solid Tumors

NCT ID: NCT01558453

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Relapsed Solid Tumor; Refractory Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eloxatin

Oxaliplatin

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

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.

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidnei Epelman

OTHER

Sponsor Role: lead

Responsible Party

Sidnei Epelman

Director of Pediatric Oncology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sidnei Epelman, MD

Role: STUDY_CHAIR

Santa Marcelina Hospital

Locations

Santa Marcelina Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

OXALI_L_04946

Identifier Type: -

Identifier Source: org_study_id