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)
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
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
Both
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
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Correlation of changes in cytokine composition and other immunologic measurements in tumor, tumor stroma and blood with benefit to talactoferrin
Outcome Description:
Descriptive statistics and trends in cytokine and immunological parameters both in the tumor biopsies and the blood samples will be summarized.
Outcome Time Frame:
Baseline and weeks 2, 7, 14, 21, and 49
Safety Issue:
No
Principal Investigator
Heather Wakelee
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Food and Drug Administration
Study ID:
VAR0072
NCT ID:
NCT01528137
Start Date:
May 2012
Completion Date:
June 2013
Related Keywords:
- 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
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Laryngeal Diseases
- Lung Neoplasms
- Tongue Neoplasms
- Carcinoma, Verrucous
- Neoplasms, Unknown Primary
- Salivary Gland Neoplasms
- Hypopharyngeal Neoplasms
- Laryngeal Neoplasms
- Paranasal Sinus Neoplasms
- Oropharyngeal Neoplasms
- Nasopharyngeal Neoplasms
Name | Location |
|---|---|
| Stanford University | Stanford, California 94305 |
