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Alkylating agents
Risk-Based Therapy for Liver Cancer
Phase 3
Waitlist Available
Led By Howard M Katzenstein
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be newly diagnosed with histologically-proven hepatoblastoma
Patients must have a performance status corresponding to ECOG scores 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years
Awards & highlights
Study Summary
This trial looks at side effects and effectiveness of different treatments for newly diagnosed liver cancer in young patients.
Who is the study for?
This trial is for young patients with newly diagnosed liver cancer called hepatoblastoma. They must not have had any previous chemotherapy or other treatments for the condition, and their organ functions should meet specific criteria. Pregnant or breastfeeding females are ineligible, as well as those on certain medications like corticosteroids or anticoagulants.Check my eligibility
What is being tested?
The study tests risk-based therapy involving surgery, various chemotherapy drugs (Dexrazoxane, Vincristine Sulfate, Fluorouracil, etc.), and potentially a liver transplant based on the stage of cancer. The aim is to see if tailoring treatment by risk group can effectively treat the cancer while minimizing side effects.See study design
What are the potential side effects?
Possible side effects include reactions to medication such as nausea, hair loss, increased infection risk due to weakened immune system from chemotherapy drugs; surgical complications; and potential issues related to liver transplantation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been recently diagnosed with hepatoblastoma.
Select...
I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Status at the End of 2 Courses of Therapy
Event-free Survival
Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed
+1 moreSecondary outcome measures
Feasibility of Referral for Liver Transplantation
Trial Design
5Treatment groups
Experimental Treatment
Group I: Very low-risk groupExperimental Treatment2 Interventions
Patients undergo surgery and then receive no further treatment.
Group II: Low-risk group (regimen T)Experimental Treatment5 Interventions
Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Group III: Intermediate-risk group (regimen F)Experimental Treatment8 Interventions
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)
Group IV: High-risk group (regimen W)Experimental Treatment7 Interventions
(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.
Group V: High-risk group (regimen H)Experimental Treatment9 Interventions
Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexrazoxane
2016
Completed Phase 2
~80
Fluorouracil
2014
Completed Phase 3
~11540
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Temsirolimus
2008
Completed Phase 2
~1940
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Liver Transplantation
2010
N/A
~4760
Vincristine Sulfate
2005
Completed Phase 3
~10150
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,127 Total Patients Enrolled
23 Trials studying Hepatoblastoma
4,391 Patients Enrolled for Hepatoblastoma
Howard M KatzensteinPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My early-stage cancer tissue wasn't reviewed within 2 weeks after surgery.I have not had chemotherapy, other cancer drugs, or experimental treatments recently.I have not had an organ transplant, am not pregnant or breastfeeding, and do not have an uncontrolled infection.I am not taking steroids, seizure medications, blood thinners, or ACE inhibitors.I have not had major surgery in the last 6 weeks.I have been recently diagnosed with hepatoblastoma.My condition requires urgent treatment due to a tumor affecting vital organ function or blood clotting issues.I was diagnosed with hepatoblastoma, met all criteria before emergency treatment, and had a confirmed diagnosis.My cancer's stage and treatment plan follows COG guidelines.I can take care of myself and perform daily activities.I am stage I and won't need chemotherapy, so my organ function isn't a concern.I am not taking strong medications that affect liver enzymes.I am using effective birth control.I have not received chemotherapy or specific treatments for hepatoblastoma before.
Research Study Groups:
This trial has the following groups:- Group 1: Very low-risk group
- Group 2: Low-risk group (regimen T)
- Group 3: High-risk group (regimen H)
- Group 4: Intermediate-risk group (regimen F)
- Group 5: High-risk group (regimen W)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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