Salivary Gland Squamous Cell Carcinoma Clinical Trial
Official title:
Enhancement of Cetuximab-Induced Antibody-Dependent Cellular Cytotoxicity (ADCC) With Lenalidomide in Advanced Solid Tumors: A Phase I/IB Study
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.
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.
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