Tremelimumab With Chemoembolization or Ablation for Liver Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01853618
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tremelimumab — DRUG
    3.5 mg/kg or 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years
  • RFA — PROCEDURE
    Performed on Day 36
  • TACE — PROCEDURE
    Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)
  • Cryoablation — PROCEDURE
    Performed on Day 36

Study Details

Background: \- Tremelimumab is a cancer treatment drug that helps the immune system recognize and destroy cancer cells. Researchers want to see if it can be used to treat advanced liver cancer. The drug will be given with one of two types of treatment for liver cancer. The first type, transarterial catheter chemoembolization (TACE), injects chemotherapy drugs into the tumor through the main blood vessel that is feeding it. That blood vessel is then closed off to help keep the drugs in the tumor longer. The second type, radiofrequency ablation (RFA), uses a heated probe to destroy the tumor tissue. Researchers want to study how safe and effective these treatments are with the study drug. Objectives: \- To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver cancer. Eligibility: \- Individuals at least 18 years of age who have advanced liver cancer that has not responded to other treatments.

Key Dates

Start date
May 2, 2013
Status verified
Nov 2019
Primary completion
Jun 7, 2017
Completion
Jun 7, 2017

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pilot 1/Arm A1-Tremelimumab + RFA or TACE
    Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
  • Experimental: 2/Arm A2 - Tremelimumab + RFA or TACE
    Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
  • Experimental: 3/Arm B - Tremelimumab + TACE
    Tremelimumab + Transarterial Catheter Chemoembolization (TACE)
  • Experimental: 4/Arm C (never opened)
    Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
  • Experimental: 5/Arm D - Tremelimumab + Cryoablation
    Tremelimumab + Cryoablation
  • Experimental: 6/Arm E - Tremelimumab + RFA
    Tremelimumab + Radiofrequency Ablation (RFA)

Primary Outcome Measure

Number of Participants With Serious and Non-Serious Adverse Events Regardless of Attribution [ Time Frame: Date treatment consent signed to date off study, approximately 44 months and 5 days for 1/Arm A1; 49 months and 26 days for 2/Arm A2; 1 month and 26 days for 3/Arm B; 30 months and 20 days for 5/Arm D; and 34 months and 25 days for 6/Arm E. ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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