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AHEP1531


Title AHEP1531: Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery
Therapeutic Area Hepatoblastoma (Tufts Children's)
Principal Investigator Jason Law, MD
Min Age 12 Years
Gender Male or Female
Contact NCCCR
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03533582?term=AHEP1531&draw=2&rank=1

Overview

This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.

Study Details

Inclusion Criteria

  1. Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution

  2. Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining

  3. Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

Exclusion Criteria

  1. Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligiblePrior solid organ transplant or allogenic stem cell transplantation

  2. Patients who are currently receiving another investigational drug

  3. Patients who are currently receiving other anticancer agents

Study Requirements

Treatment will be dependent on which arm you are randomized to. Cycles of Chemo will range from 2-6. Those who qualify will have resection at appropriate time points. There will be imaging throughout to monitor the success fo chemo or resection. There will also be an optional biology study that will require biopsies and blood draws at various times.