Study Stopped
Negative data from another trial led to termination of this trial by sponsor.
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
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)
3 other identifiers
interventional
4
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 2, 2016
July 1, 2016
3 months
February 3, 2012
July 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of changes in cytokine composition and other immunologic measurements in tumor, tumor stroma and blood with benefit to talactoferrin
Descriptive statistics and trends in cytokine and immunological parameters both in the tumor biopsies and the blood samples will be summarized.
Baseline and weeks 2, 7, 14, 21, and 49
Secondary Outcomes (6)
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
SD
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
Baseline and then every 7 weeks
- +1 more secondary outcomes
Study Arms (1)
Treatment (immunomodulator)
EXPERIMENTALPatients receive talactoferrin PO BID for 12 weeks. Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
- Agennixcollaborator
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Wakelee
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 7, 2012
Study Start
May 1, 2012
Primary Completion
August 1, 2012
Study Completion
July 1, 2013
Last Updated
August 2, 2016
Record last verified: 2016-07