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

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.

Inclusion Criteria:

Histologically or cytologically confirmed, incurable metastatic relapsed/refractory NSCLC
or relapsed/refractory, incurable, locally advanced or metastatic squamous head and neck
cancer Head and neck squamous cell cancer patients must be able to be biopsied safely in
clinic or by Stanford Interventional Radiology as determined by a Stanford Head and Neck
Oncologist or Stanford Head and Neck Surgeon Hemoglobin (Hgb) >= 9 gm/dl Platelets >=
80,000/uL International normalized ratio (INR) =< 1.5 Total bilirubin =< 1.5 Creatinine =<
1.5 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 times the
upper limit of normal Failed therapy with at least one standard first line chemotherapy
regimen, or intolerant of standard chemotherapy At least 4 weeks from the last
chemotherapy, immunosuppressive/immunomodulatory therapy or investigational agent and 2
weeks from erlotinib or other non-immunogenic therapy Palliative radiotherapy to painful
bony metastases must be completed at least 2 weeks prior to initiation of study treatment
Brain metastases must be adequately treated (stable and asymptomatic) with surgery and/or
radiation prior to enrollment and any steroids completed at least 3 weeks prior to study
treatment initiation At least one un-irradiated target lesion measurable by Response
Evaluation Criteria In Solid Tumors (RECIST) criteria At least one lesion amenable to
repeat biopsy Life expectancy of at least 2 months Eastern Cooperative Oncology Group
(ECOG) performance status 0-2 Absolute neutrophil count >= 1,000/µl Absolute lymphocyte
count >= 800/µl Ability to understand and the willingness to sign a written informed
consent document

Exclusion Criteria:

Concomitant chemotherapy, radiotherapy, immunosuppressive/immunomodulatory therapy or
investigational agents Head and Neck Squamous Cell Carcinoma that can not be safely
biopsied in Head and Neck Oncology Clinic or by Stanford Interventional Radiology as
determined by a Stanford Head and Neck Oncologist or a Stanford Head and Neck Surgeon

Co-morbid disease or incurrent illness that could affect patients' immune status or
ability to comply with the study, but not limited to:

- Renal failure requiring hemodialysis;

- New York Heart Association (NYHA) Grade III or greater congestive heart failure;

- Unstable angina;

- Severe infectious or inflammatory illness;

- Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS);

- Hepatitis (Hep) C positive (+) or Hep B surface antigen (+) Second malignancy with
less than 5 years since documented clinical remission except for non-melanoma skin
cancers or curatively treated cervical carcinoma in situ, superficial bladder cancer
or early prostate cancer Prior history of allergic reaction to compounds of similar
chemical or biologic composition to talactoferrin Inability to comply with study
and/or follow-up procedures because of psychiatric or social situations Pregnant and
nursing patients, sexually active patients (male and female) unwilling to practice
contraception while on the study and at least 30 days after completion Oral
corticosteroid therapy within 2 weeks prior to randomization or expected to be
ongoing during the study Any gastrointestinal tract disease or other medical
condition resulting in the inability to take oral medications