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Alkylating agents

Combination Chemotherapy for Liver Cancer

Phase 3
Waitlist Available
Led By Gregory M Tiao
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 or A serum creatinine based on age/gender as specified
Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; all patients with histology consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution
Must not have
Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is studying a combination of cisplatin and other drugs as a possible treatment for hepatoblastoma or hepatocellular carcinoma.

Who is the study for?
This trial is for children and young adults with hepatoblastoma or liver cancer who have undergone surgery. They must be newly diagnosed, have proper organ function, not received prior cancer treatments except certain surgeries, and agree to contraception if of childbearing potential. Those with uncontrolled infections or on other cancer drugs can't join.
What is being tested?
The study tests how well cisplatin combined with other chemotherapy drugs works after surgery in treating liver cancers in the young. It's a phase II/III trial where these drugs are given to see if they're better at killing tumor cells than one drug alone.
What are the potential side effects?
Chemotherapy may cause nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, mouth sores, and possible damage to organs like the heart and kidneys. Each drug has its own set of potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal or near normal.
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I am newly diagnosed with a specific type of liver cancer as a child.
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My body surface area is at least 0.6 square meters.
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I can take care of myself, but might not be able to do heavy physical work.
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My bilirubin levels are within 5 times the normal range for my age.
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My cancer's tissue test for INI1/SMARCB1 is positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a liver transplant for liver cancer but no other organ transplants.
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I have not had chemotherapy, radiation, or other tumor treatments before.
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I have nerve damage affecting my limbs or a history of long QT syndrome in my family.
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I have a known DPD deficiency.
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I have chronic bowel issues or I'm taking St. John's wort and can't stop before the trial.
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I do not have any infections that are currently uncontrolled.
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I am not pregnant and can take a pregnancy test if needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival (EFS)
Percentage of Group B2 participants with resectable tumors
Response rate for Group F patients
Other study objectives
Best response
Failure free survival
Overall survival
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups
Experimental Treatment
Active Control
Group I: GROUP F ARM 2 (P/GEMOX)Experimental Treatment7 Interventions
Patients receive cisplatin IV over 6 hours on day 1, doxorubicin IV over 1-15 minutes on days 1 and 2 and sorafenib PO BID on days 3-14 of cycles 1 and 3. Patients also receive gemcitabine IV over 90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 and sorafenib PO on days 1-14 of cycles 2 and 4. Patients may undergo surgery, if tumors are resectable, or receive an additional 4 cycles of the treatment. Patients may optionally undergo blood sample collection on study.
Group II: GROUP F ARM 1 (PLADO)Experimental Treatment4 Interventions
Patients receive cisplatin IV over 6 hours on day 1, doxorubicin IV over 1-15 minutes on days 1 and 2 and sorafenib PO BID on days 3-21. Treatments repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery, if tumors are resectable, or receive an additional 3 cycles of the treatment. Patients may optionally undergo blood sample collection on study.
Group III: GROUP E2 (PLADO)Experimental Treatment3 Interventions
Patients receive cisplatin IV over 6 hours on day 1 and doxorubicin IV over 1-15 minutes on days 1 and 2 following surgery. Treatments repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group IV: GROUP D2 ARM VIExperimental Treatment6 Interventions
SIOPEL-4 IV INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients receive carboplatin IV over 1 hour on days 1 and 2 and doxorubicin IV over 1-15 minutes on days 1 and 2 during cycles 1, 3 and 5. Patients also receive vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan IV over 90 minutes QD on days 1 to 5 of cycles 2, 4 and 6. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group V: GROUP D2 ARM CEExperimental Treatment5 Interventions
SIOPEL-4 IV INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients receive carboplatin IV over 1 hour on days 1 and 2, doxorubicin IV over 1-15 minutes on days 1 and 2 during cycles 1, 3 and 5, and carboplatin over 1 hour and etoposide IV over 2 hours on day 1 and 2 of cycles 2, 4 and 6. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group VI: GROUP D1Experimental Treatment4 Interventions
SIOPEL-4 INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9 during cycles 1 and 2 and days 1 and 2 during cycle 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients with lung complete remission (either with chemotherapy and/or surgery) receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1-15 minutes on days 1 and 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group VII: GROUP C ARM CDDPExperimental Treatment3 Interventions
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after cycle 2 or 4. Patients may optionally undergo blood sample collection on study.
Group VIII: GROUP C ARM C5VDExperimental Treatment5 Interventions
Patients receive cisplatin IV over 6 hours on day 1, 5-fluorouracil IV over 1-15 minutes, vincristine sulfate IV over 1 minute on days 1, 8, and 15 and doxorubicin IV over 1-15 minutes on days 1 and 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after cycle 2 or 4. Patients may optionally undergo blood sample collection on study.
Group IX: GROUP B2 ARM IIExperimental Treatment2 Interventions
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 total cycles. Patients may optionally undergo blood sample collection on study.
Group X: GROUP B2 ARM IExperimental Treatment3 Interventions
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 total cycles (4 pre-surgery, 2 post-surgery). After cycle 4, patients undergo surgery, then continue with 2 additional cycles of cisplatin. Patients may optionally undergo blood sample collection on study.
Group XI: GROUP B1 ARM 6-CDDPExperimental Treatment3 Interventions
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 6 cycles (2 pre-surgery, 4 post-surgery) in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group XII: GROUP B1 ARM 4-CDDPExperimental Treatment2 Interventions
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 4 cycles (2 pre-surgery, 2 post-surgery) in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group XIII: GROUP A2 (NON-WDF)Experimental Treatment2 Interventions
Patients receive cisplatin IV over 6 hours on day 1 following surgery. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo blood sample collection on study.
Group XIV: Group A1 (WDF)Active Control2 Interventions
Patients undergo observation. Patients may optionally undergo blood sample collection on study.
Group XV: GROUP E1Active Control3 Interventions
Patients undergo observation only. Patients may optionally undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Irinotecan
2017
Completed Phase 3
~2590
Fluorouracil
2014
Completed Phase 3
~11700
Etoposide
2010
Completed Phase 3
~2960
Doxorubicin
2012
Completed Phase 3
~8030
Cisplatin
2013
Completed Phase 3
~3120
Resection
2023
Completed Phase 2
~420
Sorafenib
2014
Completed Phase 3
~1670
Carboplatin
2014
Completed Phase 3
~6120
Gemcitabine
2017
Completed Phase 3
~1920
Oxaliplatin
2011
Completed Phase 4
~2890
Vincristine Sulfate
2005
Completed Phase 3
~10270

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
459 Previous Clinical Trials
239,390 Total Patients Enrolled
10 Trials studying Hepatoblastoma
940 Patients Enrolled for Hepatoblastoma
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,400 Total Patients Enrolled
23 Trials studying Hepatoblastoma
4,002 Patients Enrolled for Hepatoblastoma
Gregory M TiaoPrincipal InvestigatorChildren's Oncology Group

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03533582 — Phase 3
Hepatoblastoma Research Study Groups: GROUP C ARM C5VD, GROUP C ARM CDDP, GROUP D1, GROUP D2 ARM CE, GROUP F ARM 1 (PLADO), GROUP F ARM 2 (P/GEMOX), Group A1 (WDF), GROUP A2 (NON-WDF), GROUP B1 ARM 4-CDDP, GROUP B1 ARM 6-CDDP, GROUP B2 ARM I, GROUP B2 ARM II, GROUP D2 ARM VI, GROUP E1, GROUP E2 (PLADO)
Hepatoblastoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03533582 — Phase 3
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03533582 — Phase 3
~111 spots leftby Jun 2026
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