Clinical Trials Directory

Trials / Terminated

TerminatedNCT01528137

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

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)

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtalactoferrinGiven PO
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2012-05-01
Primary completion
2012-08-01
Completion
2013-07-01
First posted
2012-02-07
Last updated
2016-08-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01528137. Inclusion in this directory is not an endorsement.

Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck (NCT01528137) · Clinical Trials Directory