Liver CancerPhase 2NCT00287976
Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
A Phase 2 study testing irinotecan hydrochloride in people with Liver Cancer, run by Children's Cancer and Leukaemia Group at 22 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- irinotecan hydrochloride
- How many people
- 30 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Apr 2003to Dec 2008
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Diagnosis of hepatoblastoma
- Refractory or recurrent disease
- Failed prior first-line or second-line treatment
- Metastatic disease allowed
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Elevated serum alpha-fetoprotein (AFP) allowed
- No hepatocellular carcinoma
PATIENT CHARACTERISTICS:
- Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients > 10 years of age
- Life expectancy > 8 weeks
- Hemoglobin > 8 g/dL
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Serum bilirubin ≤ 2 times normal
- AST/ALT ≤ 2 times normal
- Serum creatinine ≤ 3 times normal
- Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate)
- Not pregnant or nursing
- No severe uncontrolled infection or enterocolitis
PRIOR CONCURRENT THERAPY:
- Recovered from toxicity of prior therapy
- No chemotherapy within 3 weeks prior to study entry
- No prior irinotecan
- No other concurrent anticancer therapy
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United Kingdom20 sites
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Royal London Hospital
London, England, E1 1BB
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Queen's Medical Centre
Nottingham, England, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma.
Secondary
- Determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug.
- Determine the time to progression and overall survival of patients treated with this drug.
- Determine the rate of resectability in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo evaluation for tumor resectability after courses 2, 3, or 4. Patients whose disease is considered resectable at any of these time points proceed to surgery.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Liver Cancer
- Being tested
- irinotecan hydrochloride
- Keywords
- childhood hepatoblastoma, recurrent childhood liver cancer
- Medical subject headings
- Liver Neoplasms, Hepatoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response (complete response and partial response)
Secondary outcomes (4)
Early progression
Death
Disease progression or recurrence
Surgical resection (complete or incomplete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startApr 2003
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Jozsef Zsiros, MD, PhD, Study chair, Emma KinderziekenhuisLaurence Brugieres, MD, Gustave Roussy, Cancer Campus, Grand ParisPenelope Brock, MD, PhD, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287976
- Sponsor's protocol ID
- CDR0000454758
- Other IDs
- CCLG-LT-2003-01, CCLG-IRINOTECAN, EU-20589
- Status last verified
- Jun 2009
- First submitted
- 6 Feb 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
- ClinicalTrials.gov ID
- NCT00287976
- Acronym / sponsor ID
- CDR0000454758
- Conditions
- Liver Cancer
- Keywords
- childhood hepatoblastoma, recurrent childhood liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Dec 2008 (estimated)
- First posted
- 7 Feb 2006 (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.
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.
Detailed description
OBJECTIVES:
Primary
- Determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma.
Secondary
- Determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug.
- Determine the time to progression and overall survival of patients treated with this drug.
- Determine the rate of resectability in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo evaluation for tumor resectability after courses 2, 3, or 4. Patients whose disease is considered resectable at any of these time points proceed to surgery.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| irinotecan hydrochloride | Drug | – |
Primary outcome
Best overall response (complete response and partial response)
4 secondary outcomes
Early progression
Death
Disease progression or recurrence
Surgical resection (complete or incomplete)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Jozsef Zsiros, MD, PhD study chair
Emma Kinderziekenhuis
Laurence Brugieres, MD
Gustave Roussy, Cancer Campus, Grand Paris
Penelope Brock, MD, PhD
Great Ormond Street Hospital for Children NHS Foundation Trust
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan hydrochloride in people with Liver Cancer, run by Children's Cancer and Leukaemia Group at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Ireland, Netherlands. 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?
Best overall response (complete response and partial response). 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 17 Sep 2013.