Oxaliplatin for Children With Solid Tumors

NCT01558453 | Unknown Phase 2

• 1 other identifier: OXALI_L_04946
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Up 2 years

Secondary Outcomes (1)

• 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).

  Up 2 years

Study Arms (1)

Eloxatin

EXPERIMENTAL

Oxaliplatin

Drug: Oxaliplatin

Interventions

Oxaliplatin 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).

Eloxatin

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≤ 21 years old at the time of cancer diagnosis.
• 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.
• All subjects should have measurable disease, at least in one dimension, 20mm minimum, or presence of neoplastic cell in cephalorachidian fluid.
• 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.
• Previous treatment:

You may not qualify if:

• Oxaliplatin previous use.
• Another chemotherapy or experimental drug, simultaneously.
• If female, pregnant or lactating.
• Active infection.
• Any serious existent condition that could affect, in adverse way, subjet's capacity to be treat according to protocol.
• 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.
• Use of investigational drug \< 30 days before entering study.
• Medical history with:
• severe renal insufficiency;
• known hypersensitiveness to platine;
• myelosuppression;
• peripheral sensory neuropathy.

Sponsors & Collaborators

• Sidnei Epelman: lead

Study Sites (1)

Santa Marcelina Hospital

São Paulo, São Paulo, 08270070, Brazil

Location

MeSH Terms

Interventions

Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Sidnei Epelman, MD

  Santa Marcelina Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Pediatric Oncology Department

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

BR (1)