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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00639509 |
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 |
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Liver Cancer |
Biological: cixutumumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular carcinoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR
PATIENT CHARACTERISTICS:
No poorly controlled diabetes mellitus
No concurrent uncontrolled illness including, but not limited to, any of the following:
No history of another primary cancer except for the following:
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
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Study Chair: | Ghassan Abou-Alfa, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David Paul Kelsen ) |
Study ID Numbers: | CDR0000589633, MSKCC-08015 |
Study First Received: | March 19, 2008 |
Last Updated: | July 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00639509 History of Changes |
Health Authority: | United States: Food and Drug Administration |
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Gastrointestinal Neoplasms |
Hepatocellular Carcinoma Adenocarcinoma Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |