Oxaliplatin for Children With Solid Tumors

Refractory Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01558453
• Other study ID #: OXALI_L_04946
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 16, 2012
• Last updated: March 25, 2013
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Hospital Santa Marcelina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms
• Refractory Solid Tumor
• Relapsed Solid Tumor

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Brazil	Santa Marcelina Hospital	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Sidnei Epelman

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.		Up 2 years	No
Secondary	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	Yes