Trial record 2 of 18 for:    catheter ablation OR cardiac ablation OR radiofrequency ablation | Open Studies | NIH, U.S. Fed

Tremelimumab With Chemoembolization or Ablation for Liver Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01853618
First received: May 2, 2013
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Liver Cell Caricinoma
Liver Cancer
Hepatocellular Carcinoma
Drug: Tremelimumab
Procedure: Trans-Arterial Cather Chemoembolization
Procedure: Radiofrequency Ablation (RFA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Tremelimumab, A Monoclonal Antibody Against CTLA-4, in Combination With Either Trans-Arterial Catheter Chemoembolization (TACE) or Radiofrequency Ablation (RFA) in Subjects With Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Safety and feasibility of combining Tremelimumab with trans-arterial catheter chemoembolization (TACE) or radiofrequency ablation (RFA) in patients with advanced HCC. [ Time Frame: 4/10/13 to 12/31/2015 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tremelimumab
    N/A
    Procedure: Trans-Arterial Cather Chemoembolization
    N/A
    Procedure: Radiofrequency Ablation (RFA)
    N/A
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 CTLA4. Anti-CTLA4 therapy has been shown to enhance anti-tumor immunity by blocking tumor-induced immune suppression of cytotoxic T cells.

Both trans-arterial catheter chemoembolization (TACE) and radiofrequency ablation (RFA) have been shown to induce a peripheral immune response.

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.

Objectives:

Primary:

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

Secondary:

To evaluate the following in patients with advanced HCC undergoing TACE or radiofrequency ablation (RFA) in combination with Tremelimumab:

  • changes in immune parameters in the peripheral blood
  • clinical indicators of efficacy (response rate, time to tumor progression, overall survival)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

2.1.1.1 Patients must have histopathological confirmation of hepatocellular carcinoma (HCC) by the Laboratory of Pathology of the 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. Fibrolammelar variant is also allowed.

2.1.1.2 Patients must have disease that is not amenable to potentially curative resection, transplantation or ablation. For Cohort A patients must have progressed on or been intolerant of prior sorafenib therapy.

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

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

2.1.1.5 Age greater than or equal to 18 years

2.1.1.6 Life expectancy of greater than 3 months.

2.1.1.7 ECOG performance status 0-2.

2.1.1.8 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 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 ALT or 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

2.1.1.9 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.

2.1.1.10 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).

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

EXCLUSION CRITERIA:

2.1.2.1 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.

2.1.2.2 Patients who have undergone prior liver transplantation are ineligible.

2.1.2.3 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.

2.1.2.4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.

2.1.2.5 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.

2.1.2.6 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.

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

2.1.2.8 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.

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

2.1.2.10 History of sarcoidosis syndrome

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

2.1.2.12 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.

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

2.1.2.14 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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853618

Contacts
Contact: Suzanne Fioravanti, R.N. (301) 594-6544 fioravas@mail.nih.gov
Contact: Tim F Greten, M.D. (301) 451-4723 gretentf@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Tim F Greten, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01853618     History of Changes
Other Study ID Numbers: 130120, 13-C-0120
Study First Received: May 2, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Liver Cancer
Monoclonal Antibody
CTLA-4
Ablative Therapy

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Antibodies, Monoclonal
Tremelimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014