Status:
COMPLETED
Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief 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. Talac...
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 inv...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- 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
- EXCLUSION CRITERIA:
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
June 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00923741
Start Date
June 19 2008
End Date
February 1 2010
Last Update
July 5 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892