Clinical Trial: Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase Ib Immunomodulatory Study of Single Agent Talactoferrin in Patients With Select Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC) and Squamous Head and Neck Cancer (HNSCC)

Brief Summary: 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

Detailed Summary:

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.


Sponsor: Stanford University

Current Primary Outcome: Correlation of changes in cytokine composition and other immunologic measurements in tumor, tumor stroma and blood with benefit to talactoferrin [ Time Frame: Baseline and weeks 2, 7, 14, 21, and 49 ]

Descriptive statistics and trends in cytokine and immunological parameters both in the tumor biopsies and the blood samples will be summarized.


Original Primary Outcome: cytokine composition [ Time Frame: 1 year ]

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. To be measured at baseline and weeks 2, 7, 14, 21 and 49.


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: 1 year ]
    To be measured from start of treatment to time of documented progression or death up to at least 12 months
  • Objective Response Rate (ORR) [ Time Frame: 1 year ]
    To be measured at baseline and then every 7 weeks
  • Stable Disease (SD) [ Time Frame: 1 year ]
    To be measured at baseline and then every 7 weeks.
  • Overall Survival (OS) [ Time Frame: 1 year ]
    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


Information By: Stanford University

Dates:
Date Received: February 3, 2012
Date Started: May 2012
Date Completion:
Last Updated: July 30, 2016
Last Verified: July 2016