Title (COG AHEP0731) Treatment of Children with All Stages of Hepatoblastoma
Principal Investigator Martin Brecher, MD
Study Number 167009
Summary The primary goal of AHEP0731 is to show that a risk-based treatment approach will maintain or improve EFS, decrease acute and long-term chemotherapy toxicity, and identify new agents for the treatment of children with hepatoblastoma.
- Patients must be less than or equal to 21 years of age at the time of diagnosis
- Patients must be newly diagnosed with histologically-proven hepatoblastoma. Except in emergent situations when a patient meets all eligibility criteria and has all baseline test but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy to confirm diagnosis. All stages of hepatoblastoma with all histologic variants are eligible for this protocol
- Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients less than or equal to 16 years of age
- Patients may have had surgical resection of some or all sites of hepatoblastoma prior to enrollment
- Organ function requirements are not required for enrolled patients who are Stage I, PFH and will not be receiving chemotherapy. However, for all other stages, adequate renal, liver, bone marrow and cardiac functions are required.
- Patients with Stage I or II disease who do not have specimens submitted for rapid central pathology review by Day 14 after initial surgical resection
- Patients that have been previously treated with chemotherapy for hepatoblastoma or other hepatoblastoma directed therapy are not eligible. Patients who have received any prior chemotherapy are not eligible
- Females who are pregnant or breast feeding are not eligible for this study since fetal toxicities and teratogenic effects have been noted for several of the study drugs. Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. Males and females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method.