Relapsed Solid TumorPhase 2NCT01558453
Oxaliplatin for Children With Solid Tumors
A Phase 2 study testing Oxaliplatin in people with Relapsed Solid Tumor and Refractory Solid Tumor, run by Sidnei Epelman at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Relapsed Solid Tumor, Refractory Solid Tumor
- What is being tested?
- Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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:
- 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.
- 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.
- 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.
- For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day 0.
- 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
- It should not have known curative treatment option and no proved therapy that increased survival with quality of life.
Who cannot join
- 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.
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- Use of investigational drug < 30 days before entering study.
- Medical history with:
- severe renal insufficiency;
- known hypersensitiveness to platine;
- myelosuppression;
- peripheral sensory neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Relapsed Solid Tumor, Refractory Solid Tumor
- Being tested
- Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Eloxatin | Experimental | Oxaliplatin Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.
Measured: 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).
Determine response time and overall survival in these patients.
Measured: Up 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidnei Epelman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sidnei Epelman, Hospital Santa Marcelina
- Investigators
- Sidnei Epelman, MD, Study chair, Santa Marcelina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558453
- Sponsor's protocol ID
- OXALI_L_04946
- Status last verified
- Mar 2013
- First submitted
- 16 Mar 2012
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01558453
- Acronym / sponsor ID
- OXALI_L_04946
- Conditions
- Relapsed Solid Tumor, Refractory Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidnei EpelmanUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eloxatin | Experimental | Drug: OxaliplatinOxaliplatin |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (29 listed)
- 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:
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinOxaliplatin 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). | Drug | Eloxatin |
Primary outcome
Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.
Time frame: Up 2 years
1 secondary outcome
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).
Time frame: Up 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidnei Epelman, MD study chair
Santa Marcelina Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin in people with Relapsed Solid Tumor and Refractory Solid Tumor, run by Sidnei Epelman at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis. (time frame: Up 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.