Expired Study
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New York, New York 10065


Purpose:

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


Study summary:

PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) at 4 months in patients with advanced hepatocellular carcinoma (HCC) treated with anti-IGF-1R recombinant monoclonal antibody IMC-A12. II. To determine the best overall response rate in patients treated with this drug. SECONDARY OBJECTIVES: I. To determine the median overall survival of patients treated with this drug. II. To evaluate the safety, tolerability, and adverse events profile of this drug in these patients. III. To perform a subgroup analysis to compare PFS of patients with advanced HCC who are hepatitis B positive/hepatitis C negative versus patients who are hepatitis B negative/hepatitis C positive treated with this drug. IV. To store pre-therapy paraffin embedded tumor tissue for future tissue-based correlative studies. V. To evaluate tumor necrotic areas using a new volumetric method of assessing non-viable tumor as a correlate for response. VI. To prospectively validate and compare the CLIP and the GDETCH staging systems and additional prognostic factors. OUTLINE: Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo serum sample collection at baseline for future tissue-based correlative studies. Previously collected paraffin embedded tumor tissue samples are also stored for future correlative studies. After completion of study treatment, patients are followed every 3 months for at least 1 year.


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


NCT ID:

NCT00639509


Primary Contact:

Principal Investigator
Ghassan Abou-Alfa
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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