Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

S
Sandeep Batra, MD

Primary Investigator

Administratively Closed
30 years or below
All
Phase N/A
2 Locations

Brief description of study

This trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

The purpose of this study is to reduce therapy associated toxicity for patients with non-metastatic hepatoblastoma (HB) and hepatocellular carcinoma (HCC) without adversely affecting long term outcomes; and to determine the event-free survival (EFS) in patients with HB whose tumor is completely resected at diagnosis and either receive no adjuvant chemotherapy (completely resected well differentiated fetal histology HB) or 2 cycles of standard dose cisplatin monotherapy (completely resected non-well differentiated fetal histology HB ? 100 mg/m^2/cycle given 3 weeks apart).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: liver cancer,hepatoblastoma,childhood hepatocellular carcinoma,childhood malignant liver neoplasm,elevated alpha-fetoprotein,SMARCB1 gene mutation, Riley
  • Age: 30 years or below
  • Gender: All

Inclusion Criteria
Patients must be newly diagnosed with hepatoblastoma or hepatocellular carcinoma
Exclusion Criteria
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 eligible
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection
Patients who previously received a solid organ transplant
This criteria apply ONLY to patients who will receive chemotherapy (all groups other than Group E1):
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Note for Group F: patients of childbearing potential should use effective birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment

Additional Information:

Participants will not be paid for their participation.
 

Updated on 05 Dec 2024. Study ID: PHO-COG-AHEP1531

Interested in the study?

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