talactoferrin in treating patients with relapsed or refractory non-small cell lung cancer or squamous cell head and neck cancer

Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage III Salivary Gland Cancer; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage III Verrucous Carcinoma of the Larynx; Stage III Verrucous Carcinoma of the Oral Cavity; Stage IV Non-small Cell Lung Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer

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

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.

Eligibility criteria:
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) =\ = 1,000/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