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

Phase 1

Terminated

• Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Interventions: Biological: talactoferrin; Other: laboratory biomarker analysis

• Registration Number: NCT01528137
• Lead Sponsor: Stanford University

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

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 Timeline

• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-07
• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2013-07
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-30
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (immunomodulator)	talactoferrin	Patients receive talactoferrin PO BID for 12 weeks. Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity.
Treatment (immunomodulator)	laboratory biomarker analysis	Patients receive talactoferrin PO BID for 12 weeks. Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Correlation of changes in cytokine composition and other immunologic measurements in tumor, tumor stroma and blood with benefit to talactoferrin	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

Name	Time	Method
SD	Baseline and then every 7 weeks
PFS	Duration of time from start of treatment to time of documented progression or death up to at least 12 months
ORR	Baseline and then every 7 weeks
OS	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
Disease stability	At 7 weeks

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States