IMC-A12 in Treating Patients With Advanced Liver Cancer
Condition: Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: cixutumumab; computed tomography; contrast-enhanced magnetic resonance imaging
Intervention description: Given IV; Undergo contrast-enhanced computed tomography; Undergo contrast-enhanced magnetic resonance imaging
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well IMC-A12 works in treating patients with advanced
      liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed hepatocellular carcinoma

               -  Unresectable, locally advanced, or metastatic disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  Child's Pugh score A5, A6, B7, or B8

          -  No known brain metastases

          -  No history of primary CNS tumors

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Life expectancy > 3 months

          -  Leukocytes ≥ 3,000/mcL

          -  Absolute neutrophil count ≥ 1,500/mcL

          -  Platelet count ≥ 75,000/mcL

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN)

          -  AST/ALT ≤ 2.5 times ULN

          -  PT/INR ≤ 1.7 times ULN

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

          -  Fasting serum glucose ≤ 125 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No clinical encephalopathy

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12

          -  No poorly controlled diabetes mellitus

               -  Patients with a history of diabetes mellitus are eligible provided their blood
                  glucose is within normal range (fasting blood glucose < 120 mg/dL OR below ULN)
                  and patient is on a stable dietary or therapeutic regimen for this condition

          -  No concurrent uncontrolled illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situation that would preclude compliance with study
                  requirements

          -  No history of seizures not well controlled with standard medical therapy

          -  No history of stroke

          -  No history of another primary cancer except for the following:

               -  Curatively resected nonmelanoma skin cancer

               -  Curatively treated carcinoma in situ of the cervix

               -  Other primary solid tumor with no known active disease present that in the
                  opinion of the investigator would not affect treatment outcome

          -  Prior local therapy (i.e., surgery, radiotherapy, hepatic arterial embolization,
             radiofrequency ablation, percutaneous ethanol injection, or cryoablation) allowed
             provided the target lesion has not been treated with local therapy and/or the target
             lesion within the field of local therapy has shown an increase of ≥ 25% in size

               -  At least 4 weeks since prior local therapy

          -  No prior systemic therapy except for sorafenib tosylate

          -  No prior agents targeting the IGF or IGF-1R pathway

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No concurrent anticancer therapy