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IMC-A12 in Treating Patients With Advanced Liver Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00639509
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well IMC-A12 works in treating patients with advanced liver cancer.


Condition Intervention Phase
Liver Cancer
Drug: cixutumumab
Phase II

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival (PFS) rate at 4 months [ Designated as safety issue: No ]
  • Best overall response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall and median survival [ Designated as safety issue: No ]
  • Safety, tolerability, and adverse events profile [ Designated as safety issue: Yes ]
  • Differences in the PFS of patients who are hepatitis B positive/hepatitis C negative versus patients who are hepatitis B negative/hepatitis C positive [ Designated as safety issue: No ]
  • Ability of the volumetric method to assess response to treatment compared to standard RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.
  • To determine the best overall response rate in patients treated with this drug.

Secondary

  • To determine the median overall survival of patients treated with this drug.
  • To evaluate the safety, tolerability, and adverse events profile of this drug in these patients.
  • 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.
  • To store pre-therapy paraffin embedded tumor tissue for future tissue-based correlative studies.
  • To evaluate tumor necrotic areas using a new volumetric method of assessing non-viable tumor as a correlate for response.
  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639509

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Ghassan Abou-Alfa, MD     212-639-3112        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Ghassan Abou-Alfa, MD Memorial Sloan-Kettering Cancer Center
Investigator: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000589633, MSKCC-08015
Study First Received: March 19, 2008
Last Updated: December 20, 2008
ClinicalTrials.gov Identifier: NCT00639509  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Recurrence
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009