Status:
COMPLETED
IMC-A12 in Treating Patients With Advanced Liver Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 I...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00639509
Start Date
March 1 2008
End Date
February 1 2011
Last Update
May 23 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065