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 increase the number of hepatoblastoma patients for whom the disease is eliminated and doesn’t come back and to decrease the side effects of chemotherapy. 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. For patients with disease that is considered High Risk, the investigational agent Temsirolimus has been added to the backbone of FDA approved chemotherapy regimen in hopes of improving outcome. The treatment you receive will be based on the chance of the disease coming back after treatment (very low, low, intermediate or high risk). Patients considered Very Low Risk after surgery will have no further treatment and will be observed carefully using the same follow-up visit schedule as patients receiving chemotherapy (7 visits the first year, 4 visits the second year, 3 visits the 3rd year, 2 visits the 4th year and then annually for up to 10 years). Low Risk patients will receive two cycles of chemotherapy (a reduction from the standard 4 cycles). Intermediate Risk patients will be treated with 6 cycles of chemotherapy (which is standard) but an additional drug will be added to the regimen to help improve outcome. [Please note, the Intermediate Risk arm is closed at the present time - enough patients have been enrolled answer the study question.] High Risk patients will be treated with 2 cycles of a regimen which includes the investigational agent Temsirolumus. Evaluation of response after these two cycles will determine if treatment will include 10 additional cycles of chemotherapy (4 with the regimen including the investigational agent and 6 with a regimen which adds an additional chemotherapy drug to the standard drugs used) OR 6 cycles of the regimen not including the investigational agent but using a standard regimen with an additional chemotherapy drug. Up to 8 more visits might be required for High Risk patients depending which treatment is received. These extra visits will last from 2-6 hours . All subjects will be asked to visit the doctor’s office for follow-up exams for up to ten years after enrolling in the study (schedule listed in the section describing the Very Low Risk regimen). -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

No Compensation

Candy Hudspeth

ckh3k@virginia.edu

4349821091