Non-Small Cell Lung CancerPhase 1NCT00923741
Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
A Phase 1 study testing Talactoferrin and Apheresis in people with Non-Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Talactoferrin and Apheresis
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2008to 1 Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Histologically or cytologically confirmed progressive, recurrent, or refractory stage IIIB or IV NSCLC; confirmation of pathologic diagnosis to be conducted at the NCI Laboratory of Pathology
- Patients may not be eligible for other curative intent treatment (e.g., surgical resection). For the purpose of eligibility for this trial, the above-cited disease states are defined as follows:
- Progressive NSCLC defined as increasing measurable disease, or the appearance of new measurable disease by RECIST criteria.
- Recurrent NSCLC defined as the reappearance of measurable disease or the appearance of new measurable disease by RECIST criteria after prior successful treatment or complete response.
- Refractory NSCLC defined as achieving less than a complete response and having residual measurable disease by RECIST criteria after prior treatment with chemotherapy, targeted or small molecules, monoclonal antibodies, or any combination of these.
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- Patients may enroll who are not candidates for, or who have documented refusal to receive standard therapy (e.g., chemotherapy) for their disease.
- HLA-A2 allele
- Patient must have evaluable or measurable disease
- Total bilirubin less than or equal to 1.5 mg/dL (OR in patients with Gilbert s syndrome, a total bilirubin less than or equal to 3.0)
- Creatinine less than 1.5 times Upper Limit of Normal (ULN) if greater than 1.5 times ULN, creatinine clearance on a 24 hour urine collection of greater than 60 mL/min.
- AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times the upper limit of normal (ULN); in case of liver metastases less than or equal to 5 x ULN
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Able to understand and give informed consent
- Recovered completely from any reversible toxicity associated with recent therapy. Typically this is 3-4 weeks for patients who most recently received cytotoxic therapy except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery.
- Hematological eligibility parameters (within 16 days of starting therapy):
- Granulocyte count greater than or equal to 1,500/mm(3)
- Platelet count greater than or equal to 75,000/mm(3)
- Hgb greater than or equal to 9 Gm/dL
Who cannot join
- Presence of brain metastases, unless the patient received brain irradiation at least 4 weeks prior to enrollment, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to registration
- History of allergic reactions to compounds of similar chemical or biologic composition to Talactoferrin. At this point, no specific compounds have been identified.
- History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for greater than or equal to 5 years
- Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- Serious active infection
- Psychiatric illness/ social situations that would limit study compliance
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- Other uncontrolled serious chronic disease or conditions that in the investigator s opinion could render compliance or follow-up in the protocol problematic
- Concurrent radiotherapy or radiotherapy within 4 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
- Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted.
- HIV positive
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
- History of opportunistic infections
- Hepatitis B surface antigen positive or hepatitis C positive
- Receipt of any investigational medication within 4 weeks prior to enrollment.
- Pregnant or lactating patients, or fertile female patients with a positive pregnancy test (serum beta-human chorionic gonadotropin [beta-hCG] at screening and at baseline), or fertile female patients unwilling to use adequate contraception (including condom use, birth control pills, or IUD) during treatment and 30 days after completion of treatment
- Sexually active male patients unwilling to practice contraception (condom use) while participating on the study and up to 30 days after completion of treatment
- Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: An Open Label Pilot Study to Evaluate the Effect on the Immune System of Talactoferrin in Adults With Non-Small Cell Lung Cancer (NSCLC)
Background:
More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment.
Read more
Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions such as breast milk, tears and saliva.
In previous studies, talactoferrin improved life span in patients with NSCLC without causing toxic side effects.
Objectives:
To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC.
Eligibility:
Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment.
Design:
Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks, followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on the drug side effects and the response of the tumor.
Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital signs and blood tests every 3 weeks.
CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6 weeks and 12 weeks and then every 12 weeks during the duration of treatment.
Apheresis: Quantities of white blood cells called lymphocytes are collected through a procedure called apheresis in order to measure the immune response to treatment. In this procedure, blood is collected through a needle placed in a vein in the arm (similar to donating blood) and circulated through a cell separator machine. The lymphocytes are extracted and the rest of the blood is returned to the body through the same needle.
Read the detailed description
Background:
Patients with locally advanced or metastatic NSCLC have a very poor prognosis even with surgery, chemotherapy, and radiation treatments.
Patients who respond to 1st line chemotherapy invariably develop disease progression, and their median survival is between 6-8 months.
Talactoferrin alfa (TLF) is a recombinant human lactoferrin.
TLF displays anti-infective (against bacteria, viruses, protozoa and fungi) and anti-inflammatory properties, anti-tumor activity and anti-asthma properties.
Preclinical studies have demonstrated an increase in cytokines that stimulate both innate and adaptive immunity, as well as increasing the numbers of NK-T cells and CD8+ T-lymphocytes found in Peyer s Patches.
Previous studies in NSCLC have demonstrated safety and evidence of clinical activity.
Objectives:
Primary: To evaluate the effects of administration of talactoferrin to patients with advanced non-small cell lung cancer on the quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in serum.
Secondary: To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.
Eligibility:
Patients with cytologically or histologically confirmed progressive, recurrent, or refractory stage IIIb or IV NSCLC.
Patients must be HLA-A2 positive.
Design:
Single-arm pilot study
Ten patients will be enrolled to receive daily oral talactoferrin (1.5 g/ bid) for up to 12 weeks.
Patients who benefit from treatment will be able to continue on a 12 weeks on 2 weeks off schedule until progression.
Evaluation will be performed every 3 weeks with CT chest, abdomen, and pelvis at baseline, week 6, and week 12.
Immunologic studies (including apheresis) will be performed at baseline, week 6, and week 12.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Talactoferrin, Apheresis
- Keywords
- Lung Cancer, Immunity, Clinical Response, Cytokines, Elispot Assay, Non-Small Cell Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalactoferrinDrug
ApheresisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of talactoferrin to patients with advanced NSCLC on quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in s...
Secondary outcomes (1)
To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start19 Jun 2008
- Primary completion1 Feb 2010
- Study completion1 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- James L Gulley, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923741
- Sponsor's protocol ID
- 080166
- Other IDs
- 08-C-0166
- Status last verified
- 6 Nov 2012
- First submitted
- 17 Jun 2009
- Last updated
- 5 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study to Evaluate the Effect on the Immune System of Talactoferrin in Adults With Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00923741
- Acronym / sponsor ID
- 080166
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Lung Cancer, Immunity, Clinical Response, Cytokines, Elispot Assay, Non-Small Cell Lung Cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Jun 2008
- Primary completion
- 1 Feb 2010 (actual)
- Study completion
- 1 Feb 2010 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment.
Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions such as breast milk, tears and saliva.
In previous studies, talactoferrin improved life span in patients with NSCLC without causing toxic side effects.
Objectives:
To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC.
Eligibility:
Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment.
Design:
Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks, followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on the drug side effects and the response of the tumor.
Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital signs and blood tests every 3 weeks.
CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6 weeks and 12 weeks and then every 12 weeks during the duration of treatment.
Apheresis: Quantities of white blood cells called lymphocytes are collected through a procedure called apheresis in order to measure the immune response to treatment. In this procedure, blood is collected through a needle placed in a vein in the arm (similar to donating blood) and circulated through a cell separator machine. The lymphocytes are extracted and the rest of the blood is returned to the body through the same needle.
Detailed description
Background:
Patients with locally advanced or metastatic NSCLC have a very poor prognosis even with surgery, chemotherapy, and radiation treatments.
Patients who respond to 1st line chemotherapy invariably develop disease progression, and their median survival is between 6-8 months.
Talactoferrin alfa (TLF) is a recombinant human lactoferrin.
TLF displays anti-infective (against bacteria, viruses, protozoa and fungi) and anti-inflammatory properties, anti-tumor activity and anti-asthma properties.
Preclinical studies have demonstrated an increase in cytokines that stimulate both innate and adaptive immunity, as well as increasing the numbers of NK-T cells and CD8+ T-lymphocytes found in Peyer s Patches.
Previous studies in NSCLC have demonstrated safety and evidence of clinical activity.
Objectives:
Primary: To evaluate the effects of administration of talactoferrin to patients with advanced non-small cell lung cancer on the quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in serum.
Secondary: To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.
Eligibility:
Patients with cytologically or histologically confirmed progressive, recurrent, or refractory stage IIIb or IV NSCLC.
Patients must be HLA-A2 positive.
Design:
Single-arm pilot study
Ten patients will be enrolled to receive daily oral talactoferrin (1.5 g/ bid) for up to 12 weeks.
Patients who benefit from treatment will be able to continue on a 12 weeks on 2 weeks off schedule until progression.
Evaluation will be performed every 3 weeks with CT chest, abdomen, and pelvis at baseline, week 6, and week 12.
Immunologic studies (including apheresis) will be performed at baseline, week 6, and week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age greater than or equal to 18 years
- Histologically or cytologically confirmed progressive, recurrent, or refractory stage IIIB or IV NSCLC; confirmation of pathologic diagnosis to be conducted at the NCI Laboratory of Pathology
- Patients may not be eligible for other curative intent treatment (e.g., surgical resection). For the purpose of eligibility for this trial, the above-cited disease states are defined as follows:
- Progressive NSCLC defined as increasing measurable disease, or the appearance of new measurable disease by RECIST criteria.
- Recurrent NSCLC defined as the reappearance of measurable disease or the appearance of new measurable disease by RECIST criteria after prior successful treatment or complete response.
Key exclusion criteria (17 listed)
- Presence of brain metastases, unless the patient received brain irradiation at least 4 weeks prior to enrollment, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to registration
- History of allergic reactions to compounds of similar chemical or biologic composition to Talactoferrin. At this point, no specific compounds have been identified.
- History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for greater than or equal to 5 years
- Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- Serious active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talactoferrin | Drug | – |
| Apheresis | Procedure or surgery | – |
Primary outcome
To evaluate the effects of talactoferrin to patients with advanced NSCLC on quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in s...
1 secondary outcome
To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Gulley, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talactoferrin and Apheresis in people with Non-Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of talactoferrin to patients with advanced NSCLC on quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in s.... It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.