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ProtocolTrial Name and Objective
111109

COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma

1.1.2
Stage I hepatoblastoma (non-pure fetal histology [PFH]), non-small cell undifferentiated [SCU]) and Stage II (non-SCU) is a highly curable disease with 2 cycles of adjuvant cisplatin, 5-fluorouracil, and vincristine (C5V).

1.1.3
The addition of doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma will be feasible and associated with acceptable levels of toxicity.

1.1.4
The use of vincristine and irinotecan in an upfront window for children with high-risk, metastatic hepatoblastoma will improve the response rate in this group of children.

1.1.5
Referral for orthotopic liver transplant (OTL) is feasible in a cooperative group setting in children with hepatoblastoma designated as potentially unresectable following central surgical review and staging according to the PRE TEXT (Pretreatment Extent of Disease) grouping system.

1.2 Primary Aims

1.2.1
To estimate the EFS in children with Stage I (non-PFH, non-SCU) and Stage II (non SCU) hepatoblastoma treated with surgical resection followed by 2 cycles of C5V.

1.2.2
To determine the feasibility and toxicity of adding doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.

1.2.3
To estimate the response rate to vincristine and irinotecan in previously untreated children with high-risk, metastatic hepatoblastoma.

1.2.4
To determine whether timely (between diagnosis and end of second cycle of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma.

1.2.5
To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials.
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051508

Protocol #: 20140318: A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

The primary objective of the study is to evaluate the maximum tolerated dose (MTD) of intrahepatic injection of talimogene laherparepvec into tumors of the liver, based on subject incidence of dose-limiting toxicities (DLTs), separately in subjects with primary hepatocellular carcinoma (HCC) and subjects with metastatic liver tumors (non-HCC).
The secondary objectives of the study are as follows:
* To evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver
tumors as assessed by subject incidence of treatment-emergent and
treatment-related adverse events
* To evaluate the efficacy of intrahepatic injection of talimogene laherparepvec in the overall population and by tumor type (non-HCC and HCC) as assessed by: objective response rate (ORR), best overall response (BOR), durable response rate (DRR), duration of response (DOR), response in injected and uninjected lesions, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
* To estimate the incidence of detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in blood and urine
* To estimate the incidence of clearance of talimogene laherparepvec DNA from blood and urine
* To estimate the rate of detection and incidence of talimogene laherparepvec DNA and virus at the surface of talimogene laherparepvec injection site, the exterior of the occlusive dressing, and the oral mucosa
* To estimate the incidence of talimogene laherparepvec DNA detection in lesions
suspected to be herpetic in origin

The exploratory objectives of the study are to assess blood and tumor tissue for potential biomarkers which predict and/or are correlated with clinical outcomes to talimogene laherparepvec
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