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

This study has been terminated.
(Negative data from another trial led to termination of this trial by sponsor.)
Sponsor:
Collaborators:
Agennix
Information provided by (Responsible Party):
Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier:
NCT01528137
First received: February 3, 2012
Last updated: January 27, 2014
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
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
Biological: talactoferrin
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Correlation of changes in cytokine composition and other immunologic measurements in tumor, tumor stroma and blood with benefit to talactoferrin [ Time Frame: Baseline and weeks 2, 7, 14, 21, and 49 ] [ Designated as safety issue: No ]
    Descriptive statistics and trends in cytokine and immunological parameters both in the tumor biopsies and the blood samples will be summarized.


Secondary Outcome Measures:
  • PFS [ Time Frame: Duration of time from start of treatment to time of documented progression or death up to at least 12 months ] [ Designated as safety issue: No ]
  • ORR [ Time Frame: Baseline and then every 7 weeks ] [ Designated as safety issue: No ]
  • SD [ Time Frame: Baseline and then every 7 weeks ] [ Designated as safety issue: No ]
  • OS [ Time Frame: Time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis up to at least 12 months ] [ Designated as safety issue: No ]
  • Disease stability [ Time Frame: Baseline and then every 7 weeks ] [ Designated as safety issue: No ]
  • Disease stability [ Time Frame: At 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (immunomodulator)
Patients receive talactoferrin PO BID for 12 weeks. Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity.
Biological: talactoferrin
Given PO
Other Names:
  • oral recombinant human lactoferrin
  • oral rhLF
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) =< 1.5 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528137

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Agennix
Investigators
Principal Investigator: Heather Wakelee Stanford University
  More Information

No publications provided

Responsible Party: Heather Wakelee, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01528137     History of Changes
Other Study ID Numbers: VAR0072, NCI-2012-00060, 23170
Study First Received: February 3, 2012
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014