Tremelimumab With Chemoembolization or Ablation for Liver Cancer

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Brief Title

Tremelimumab With Chemoembolization or Ablation for Liver Cancer

Official Title

A Pilot Study of Tremelimumab - A Monoclonal Antibody Against CTLA-4 in Combination With Trans-Arterial Catheter Chemoembolization (TACE), Radiofrequency Ablation (RFA), or Cryoablation in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

Brief Summary

      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.
    

Detailed Description

      Background:

      Worldwide, hepatocellular carcinoma (HCC) is the fifth most common malignancy with a median
      survival of 6-9 months. For patients with advanced disease sorafenib is the only approved
      drug and this has limited benefit.

      Tremelimumab is a monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4
      (CTLA4). Anti-CTLA4 therapy has been shown to enhance anti-tumor immunity by blocking
      tumor-induced immune suppression of cytotoxic T cells.

      Various tumor ablative procedures and techniques have been shown to result in immunogenic
      cell death and induction of a peripheral immune response. Both transarterial catheter
      chemoembolization (TACE) and radiofrequency ablation (RFA) have been shown to do this, as
      well as cryoablation and external beam radiation.

      The underlying hypothesis of this study is that the effect of anti-CTLA4 treatment can be
      enhanced by TACE or RFA in patients with advanced hepatocellular carcinoma. We will also
      evaluate this in the context of cryoablation and radiation in hepatocellular carcinoma (HCC)
      and RFA in cholangiocarcinoma.

      Objective:

      To assess the safety and feasibility of combining Tremelimumab with trans-arterial catheter
      chemoembolization (TACE) radiofrequency ablation (RFA), or cryoablation in patients with
      advanced HCC.

      Eligibility:

      Histologically or cytologically confirmed diagnosis of HCC.

      Childs-Pugh A/B7 cirrhosis only is allowed. If patient does not have cirrhosis, this
      limitation does not apply.

      Barcelona Clinic Liver Cancer (BCLC) Stage B and C patients.

      Patients must have disease that is not amenable to potentially curative resection,
      radiofrequency ablation, or liver transplantation.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With Serious and Non-Serious Adverse Events Regardless of Attribution

Secondary Outcome

 Number of Participants With Best Response

Condition

Heptocellular Cancer

Intervention

Tremelimumab

Study Arms / Comparison Groups

 Pilot 1/Arm A1-Tremelimumab + RFA or TACE
Description:  Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

61

Start Date

May 2, 2013

Completion Date

June 7, 2017

Primary Completion Date

June 7, 2017

Eligibility Criteria

        -INCLUSION CRITERIA:

          1. Patients must have histopathological confirmation of hepatocellular carcinoma (HCC) or
             (Cohort E only) biliary tract carcinoma (BTC) by the Laboratory of Pathology of the
             National Cancer Institute (NCI) prior to entering this study OR histopathological
             confirmation of carcinoma in the setting of clinical and radiological characteristics
             which, together with the pathology, are highly suggestive of a diagnosis of HCC (or
             biliary tract carcinoma in Cohort E). Fibrolammelar variant is also allowed. For
             cohort E, the term BTC includes intraor extrahepatic cholangiocarcinoma, gallbladder
             cancer or ampullary cancer, as long as there is an intrahepatic component amenable to
             radiofrequency ablation (RFA).

          2. Patients must have disease that is not amenable to potentially curative resection,
             transplantation or ablation. For Cohorts A, C and D patients must have progressed on,
             been intolerant to, or refused prior sorafenib therapy. Cohort E patients must have
             received at least one line of chemotherapy for BTC.

          3. Disease must be technically amenable to transhepatic arterial chemoembolization
             (TACE), radiofrequency ablation (RFA) or cryoablation. Each case will be discussed at
             gastrointestinal (GI) tumor board with interventional radiology. Patients must have
             evaluable disease.

          4. If liver cirrhosis is present, patient must have a Child-Pugh A/B7 classification.

          5. Age greater than or equal to 18 years

          6. Life expectancy of greater than 3 months.

          7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          8. Patients must have normal organ and marrow function as defined below:

               -  leukocytes greater than or equal to 3,000/mcL

               -  absolute neutrophil count greater than or equal to 1,000/mcL

               -  platelets greater than or equal to 60,000/mcL

               -  total bilirubin, If cirrhosis present: Part of Child Pugh requirement. If no
                  cirrhosis: Bili should be less than or equal to 2 times upper limit of normal
                  (ULN)

               -  Serum albumin, If cirrhosis present: Part of Child Pugh requirement. If no
                  cirrhosis: albumin should be greater than or equal to 2.5g/dl

               -  Patients are eligible with alanine aminotransferase (ALT) or aspartate
                  aminotransferase (AST) up to 5 times ULN.

               -  creatinine, less than 1.5 times institution upper limit of normal OR

               -  creatinine clearance greater than or equal to 45 mL/min/1.73 m(2), as calculated
                  below, for patients with creatinine levels above institutional normal

          9. Patients must have recovered from any acute toxicity related to prior therapy,
             including surgery. Toxicity should be less than or equal to grade 1 or returned to
             baseline.

         10. Patients must not have other invasive malignancies within the past 5 years (with the
             exception of non-melanoma skin cancers, non-invasive bladder cancer or localized
             prostate cancer for whom systemic therapy is not required).

         11. Patient must be able to understand and willing to sign a written informed consent
             document.

        EXCLUSION CRITERIA:

          1. Patients who have had standard of care chemotherapy, large field radiotherapy, or
             major surgery must wait 2 weeks prior to entering the study. For recent experimental
             therapies a 28 day period of time must elapse before treatment.

          2. Patients who have undergone prior liver transplantation are ineligible.

          3. Patients with known brain metastases will be excluded from this clinical trial because
             of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             systemic infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia)
             or psychiatric illness/social situations that would limit compliance with study
             requirements.

          5. History of chronic autoimmune disease (e.g., Addison's disease, multiple sclerosis,
             Graves disease, Hashimoto's thyroiditis, rheumatoid arthritis, hypophysitis, etc.)
             with symptomatic disease within the 3 years before randomization. Note: Active
             vitiligo or a history of vitiligo will not be a basis for exclusion.

          6. Dementia or significantly altered mental status that would prohibit the understanding
             or rendering of Information and Consent and compliance with the requirements of the
             protocol.

          7. Diverticulitis (either active or history of) within the past 2 years. Note that
             diverticulosis is permitted.

          8. Active or history of inflammatory bowel disease (colitis, Crohn's), irritable bowel
             disease, celiac disease, or other serious, chronic, gastrointestinal conditions
             associated with diarrhea. Active or history of systemic lupus erythematosus or
             Wegener's granulomatosis.

          9. Currently receiving immunosuppressive doses of steroids or other immunosuppressive
             medications (inhaled and topical steroids are permitted)

         10. History of sarcoidosis syndrome

         11. Patients should not be vaccinated with live attenuated vaccines within 1 month of
             starting Tremelimumab treatment.

        12 Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

        13. HIV-positive patients receiving anti-retroviral therapy are excluded from this study
        due to the possibility of pharmacokinetic interactions between antiretroviral medications
        and Tremelimumab. HIV positive patients not receiving antiretroviral therapy are excluded
        due to the possibility that Tremelimumab may worsen their condition and the likelihood that
        the underlying condition may obscure the attribution of adverse events.

        14. History of hypersensitivity reaction to human or mouse antibody products.

        15. Pregnancy and breast feeding are exclusion factors. The effects of Tremelimumab on the
        developing human fetus are unknown. Enrolled patients must agree to use adequate
        contraception (hormonal or barrier method of birth control; abstinence) prior to study
        entry, the duration of study participation and 3 months after the end of the treatment.
        Should a woman become pregnant or suspect she is pregnant while she or her partner is
        participating in this study, she should inform her treating physician immediately.

        16. Patients with unhealed surgical wounds for more than 30 days.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Tim F Greten, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01853618

Organization ID

130120

Secondary IDs

13-C-0120

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Tim F Greten, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

November 2019