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

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ClinicalTrials.gov Identifier: NCT01528137
Recruitment Status : Terminated (Negative data from another trial led to termination of this trial by sponsor.)
First Posted : February 7, 2012
Last Update Posted : August 2, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Agennix
Information provided by (Responsible Party):
Heather Wakelee, Stanford University

Study Description
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Brief 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

Condition or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Descriptive statistics and trends in cytokine and immunological parameters both in the tumor biopsies and the blood samples will be summarized.


Secondary Outcome Measures :
  1. PFS [ Time Frame: Duration of time from start of treatment to time of documented progression or death up to at least 12 months ]
  2. ORR [ Time Frame: Baseline and then every 7 weeks ]
  3. SD [ Time Frame: Baseline and then every 7 weeks ]
  4. 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 ]
  5. Disease stability [ Time Frame: Baseline and then every 7 weeks ]
  6. Disease stability [ Time Frame: At 7 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528137


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Agennix
Investigators
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Principal Investigator: Heather Wakelee Stanford University
More Information
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Responsible Party: Heather Wakelee, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01528137    
Other Study ID Numbers: VAR0072
NCI-2012-00060 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
23170 ( Other Identifier: Stanford University IRB )
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Squamous Cell Carcinoma of Head and Neck
Salivary Gland Neoplasms
Nasopharyngeal Carcinoma
Paranasal Sinus Neoplasms
Neoplasms, Unknown Primary
Tongue Neoplasms
Laryngeal Diseases
 Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases