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

Not Recruiting

Trial ID: NCT01528137


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

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)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

John B. Sunwoo, MD
John B. Sunwoo, MD

Edward C. and Amy H. Sewall Professor in the School of Medicine and Professor, by courtesy, of Dermatology

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


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


biological: talactoferrin

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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