This phase I trial studies how well talactoferrin works in treating patients with relapsed or refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer. Biological therapies, such as talactoferrin, may stimulate the immune system in different ways and stop tumor cells from growing
PRIMARY OBJECTIVES: I. Monitoring of immunologic response to therapy in tumor tissue and peripheral blood. Identification of potential candidate biomarkers indicating clinical benefit to talactoferrin. SECONDARY OBJECTIVES: I. Progression free survival (PFS), objective response rate (ORR), stable disease (SD), overall survival (OS), disease stability, and disease stability at 7 weeks. OUTLINE: Patients receive talactoferrin orally (PO) twice daily (BID) for 12 weeks. Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for at least 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Given PO
Correlative studies
Stanford University
Stanford, California, United States
Correlation of changes in cytokine composition and other immunologic measurements in tumor, tumor stroma and blood with benefit to talactoferrin
Descriptive statistics and trends in cytokine and immunological parameters both in the tumor biopsies and the blood samples will be summarized.
Time frame: Baseline and weeks 2, 7, 14, 21, and 49
PFS
Time frame: Duration of time from start of treatment to time of documented progression or death up to at least 12 months
ORR
Time frame: Baseline and then every 7 weeks
SD
Time frame: Baseline and then every 7 weeks
OS
Time frame: Time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis up to at least 12 months
Disease stability
Time frame: Baseline and then every 7 weeks
Disease stability
Time frame: At 7 weeks
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