Oxaliplatin for Children With Solid Tumors

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

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.

Study Overview

• Status: Unknown
• Conditions: Relapsed Solid Tumor; Refractory Solid Tumor
• Intervention / Treatment: Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 08270070
      • Santa Marcelina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eloxatin; Oxaliplatin	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.	Up 2 years

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sidnei Epelman
• Investigators: Study Chair: Sidnei Epelman, MD, Santa Marcelina Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 25, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: OXALI_L_04946