Clinical trial for patients less than 22 years old with newly diagnosed hepatoblastoma (any stage)


14764

Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (IND#122782, NSC#683864) Added to High Risk Stratum Treatment

Pediatrics

Dunsmore Kimberly, P

UVa Health System, Department of Pediatrics seeks: children, adolescents, women and men with hepatoblastoma for research study. The patient must be less than 22 years old at the time of diagnosis. Patients with hepatoblastoma are commonly treated with chemotherapy, surgery and when necessary liver transplant. The overall goal of this study is to get rid of the cancer and not have it come back in more children with hepatoblastoma and to decrease the side effects of chemotherapy. In this study, the risk level for the disease coming back after treatment is either very low, low, intermediate or high. Patients are treated according to the risk group they are in. The study involves taking FDA approved chemotherapy agents and the following standard of care tests: blood draws, physical exams, urinalyses, tumor biopsy (in certain situations), CT/MRI, bone scans and surgery. The treatment you receive will be based on the chance of the disease coming back after treatment (very low, low, intermediate or high risk). Very low-risk and intermediate-risk patients will have no extra visits compared to non-study treatment. Low-risk patients will have up to 8 fewer clinic visits over 6 weeks compared to non-study treatment. High-risk patients will have 8 more clinic visits over 6 weeks compared to non-study treatment. These extra visits will last from 2-6 hours . All subjects will be asked to visit the doctors office for follow-up exams for at least 10 years after the last patient starts the study. You and/or your insurance will be billed for all study related medication, tests, treatment, and procedures. No compensation is provided for this study. Contact Information: For more information please contact: " Candace Hudspeth, CCRC " Tel: 434-982-1091 Email: ckh3k@virginia.edu " IRB-HSR # 14764 (COG AHEP0731) Principal Investigator: Kimberly P. Dunsmore, MD

Hematology/Oncology


Pediatric Cancers: Liver Cancer

Pediatrics
Cancer (Oncology)

Ill


Candy Hudspeth

ckh3k@virginia.edu

4349821091