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Investigator(s):
James L. Gulley, M.D., Ph.D., F.A.C.P. Principal Investigator Phone: 301-435-2956 gulleyj@mail.nih.gov	Giuseppe Giaccone, M.D., Ph.D. Lead Investigator Phone: 301-496-4916 Fax: 301-402-0172 giacconeg@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Mary Pazdur, C.R.N.P. Nurse Practitioner Phone: 301-496-7870 Fax: 301-480-5094 pazdurm@mail.nih.gov	Oksook Heath, R.N., B.S.N. Research Nurse Phone: 301-496-9812 Fax: 301-480-1779 oheath@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLS)
• At least one prior systemic therapy for advanced or metastatic NSCLC
• HLA-A2 positive
• Evaluable or measurable disease
• Total bilirubin ≤ 1.5 mg/dL (≤ 3 mg/dL in patients with Gilbert’s)
• AST/ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver metastases are present)
• Creatinine < 1.5 x ULN OR creatinine clearance > 60 mL/min
• ECOG 0–2
• Able to understand and give informed consent
• Recovered from all prior therapy
• > 4 weeks since prior and no concurrent radiotherapy
• No prior radiotherapy to the target lesion sites
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Hemoglobin ≥ 9 g/dL
• No other concurrent anticancer therapy
• No concurrent topical steroids (including steroid eye drops) or systemic steroids; nasal or inhaled steroids allowed
• Brain metastases allowed provided the metastases were previously treated with brain irradiation ≥ 4 weeks ago AND patient is stable, asymptomatic, and off steroids for ≥ 4 weeks prior to study entry
• Not pregnant or nursing; sexually active patients must use contraception during and for 30 days after completion of study treatment
• No history of allergic reactions to compounds of similar chemical or biologic composition to Talactoferrin
• No history of other malignancies except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, prostate cancer, superficial bladder cancer, or other curatively treated solid tumor with no evidence of disease for ≥ 5 years
• No history of opportunistic infection or serious active infection
• No primary immunodeficiency
• HIV negative
• Hepatitis B surface antigen and hepatitis C antibody negative
• No other medical condition that would preclude study participation
• No receipt of any investigational medication within 4 weeks prior to enrollment

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Study Outline:

• Patients receive oral Talactoferrin twice daily for 12 weeks and 2 weeks off
• Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity
• Apheresis will be performed at baseline, 6 weeks, and 12 weeks
• CT scan of chest/abdomen/pelvis will be performed at baseline, 6 weeks, 12 weeks, and every 12^th week of each cycle
• Patients undergo periodic blood sample collection

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/8/09
Updated: 11/12/08