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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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081317

NCI/CTEP# 9144: A Phase II Study of Bevacizumab Alone or in Combination with TRC105 for Advanced Renal Cell Cancer

To compare the progression-free survival at 12 and 24 weeks for bevacizumab alone or in combination with TRC105

Secondary endpoints will include toxicity and RECIST response rate for the
combination compared to single agent bevacizumab.

Correlative endpoints:
To evaluate tumor tissue expression of CD105, TGFâ-RII, ACVRL1 and TGFBR1
kinase from pre- and post-treatment tissue samples in order to determine whether
CD105 and stem cell activation occurs after exposure to anti-VEGF therapy as
predicted by laboratory models, and whether exposure to TRC105 affects these
changes. A primary goal of tissue analysis will be to generate preliminary data to correlate levels of CD105, TGFâ-RII, ACVRL1 and TGFBR1 in tissue with response to bevacizumab in combination with TRC105 compared to bevacizumab alone. To compare the soluble CD105 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with TRC105.

To compare TGFâ-RII levels at baseline and after treatment between the group
receiving bevacizumab alone and the group receiving bevacizumab in combination
with TRC105.

To evaluate whether circulating tumor cells (CTCs) can be detected in this patient population using parylene membrane filter technology, and whether changes in CTC counts and CD105 expression on CTCs during therapy correspond to imaging and clinical response
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