Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
|First Received Date ICMJE||June 17, 2009|
|Last Updated Date||May 3, 2013|
|Start Date ICMJE||June 2008|
|Primary Completion Date||February 2010 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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...|
|Original Primary Outcome Measures ICMJE
||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 serum.|
|Change History||Complete list of historical versions of study NCT00923741 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer|
|Official Title ICMJE||An Open Label Pilot Study to Evaluate the Effect on the Immune System of Talactoferrin in Adults With Non-Small Cell Lung Cancer (NSCLC)|
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.
To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC.
Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment.
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.
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.
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.
Patients with cytologically or histologically confirmed progressive, recurrent, or refractory stage IIIb or IV NSCLC.
Patients must be HLA-A2 positive.
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 Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Non-Small Cell Lung Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2010|
|Primary Completion Date||February 2010 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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:
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):
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
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.
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
|Ages||18 Years to 90 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00923741|
|Other Study ID Numbers ICMJE||080166, 08-C-0166|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2012|
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