Clinical Trials Directory

Trials / Completed

CompletedNCT01254617

Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer

Enhancement of Cetuximab-Induced Antibody-Dependent Cellular Cytotoxicity (ADCC) With Lenalidomide in Advanced Solid Tumors: A Phase I/IB Study

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
24 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving lenalidomide together with cetuximab may be a better treatment for colorectal cancer or head and neck cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose of lenalidomide when given in combination with cetuximab in patients with advanced colorectal or squamous cell head and neck cancer. SECONDARY OBJECTIVES: I. To evaluate response in refractory V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal and head/neck cancers as monitored by measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. II. To measure antibody-dependent cytotoxic activity (ADCC) in patients receiving lenalidomide plus cetuximab. III. To measure natural killer cell cytokine production in patients receiving lenalidomide plus cetuximab. IV. To describe fragment c gamma receptor polymorphisms. (Exploratory) V. To describe baseline immune cell function. (Exploratory) OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and cetuximab intravenously (IV) over 1-2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 6 weeks.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCetuximabGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGLenalidomideGiven PO

Timeline

Start date
2011-02-10
Primary completion
2014-01-29
Completion
2014-01-29
First posted
2010-12-06
Last updated
2020-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01254617. Inclusion in this directory is not an endorsement.