Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

NCT00287976 | Unknown Phase 2

• 4 other identifiers: CDR0000454758CCLG-LT-2003-01CCLG-IRINOTECANEU-20589
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 22

Brief 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.

Conditions

Liver Cancer

Keywords

childhood hepatoblastoma; recurrent childhood liver cancer

Outcome Measures

Primary Outcomes (1)

• Best overall response (complete response and partial response)

Secondary Outcomes (4)

• Early progression

• Death

• Disease progression or recurrence

• Surgical resection (complete or incomplete)

Interventions

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (22)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Emma Kinderziekenhuis

Amsterdam, NL-1100 DE, Netherlands

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Liver Neoplasms; Hepatoblastoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jozsef Zsiros, MD, PhD

  Emma Kinderziekenhuis

  STUDY CHAIR

• Laurence Brugieres, MD

  Gustave Roussy, Cancer Campus, Grand Paris

• Penelope Brock, MD, PhD

  Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: April 1, 2003
• Primary Completion: December 1, 2008
• Last Updated: September 17, 2013

Record last verified: 2009-06

Locations

GB (20); NL (1); IE (1)