The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body’s normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug in combination with docetaxel (an approved drug for treating NSCLC) can be given to patients with NSCLC without causing unacceptable side effects.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: ABR-217620, naptumomab estafenatox  Drug: docetaxel	Phase I

Further Study Details: 

Primary Outcomes: Side effect profile (based on blood pressure, body temperature, and laboratory tests assessed from screening through Day 56)
Secondary Outcomes: Pharamcokinetic parameters (Days 1 and 4 of each cycle); Immunological response; Changes in anti-SEA/E-120 levels; Objective response rate; Time to progression and survival (followed for up to 1 year).
Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Signed written informed consent.
• Patients with histologically or cytologically confirmed advanced NSCLC who have progressed on first line platin-based therapy or declined standard regimen.
• Age ≥ 18.
• ECOG performance status 0 or 1.
• Adequate bone marrow function: absolute neutrophil count ≥ 1500/mm3, WBC ≥ 3000/mm3, platelets ≥ 100,000/mm3, and hemoglobin ≥ 10 g/dL.
• Adequate renal function: creatinine ≤ 1.5 × upper limit of normal (ULN).
• Adequate hepatic function: bilirubin < ULN, and SGOT (AST) and SGPT (ALT) to < 1.5 × ULN concomitant with alkaline phosphatase (ALP) < 2.5 ULN.
• Patient willing and able to comply with hospitalization for treatment and follow-up visits.

Exclusion Criteria:

• Female patients who are pregnant or nursing or planning to become pregnant during the study. Fertile, sexually active women not willing to practice reliable contraceptive. Male patients with partners of childbearing potential not using acceptable contraceptive method.
• A serious uncontrolled medical disorder or active infection including unexplained fever (> 100.5°F or 38.1°C) that would impair the patient’s ability to receive study treatment.
• Any concurrent malignancy, except for the following malignancies that may be included: non-melanoma skin cancer, cervical cancer in situ, DCIS or LCIS of breast, past history of prostate cancer without clinical evidence of disease (includes patients receiving hormonal therapy).
• History of brain metastases, unless stable for more than 4 weeks, and not requiring steroid therapy and without clinical symptoms of brain metastases.
• Significant symptomatic cardiac disease including history (within past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension requiring treatment with more than 2 drugs.
• History of or current arrhythmias requiring treatment, except for non-specific, asymptomatic ST-T wave changes or extrasystoles.
• Seizure disorder requiring therapy.
• Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5-day treatment + 1 day in-patient follow-up), and within 5 days before start of ABR-217620 treatment.
• Simultaneous participation in any other investigational drug study or participation in a study less than 4 weeks before start of study treatment.
• Treatment with systemic or inhaled corticosteroids within 2 weeks before start of treatment.
• Treatment with anticoagulants, except when used to maintain the patency of a central venous line.
• Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis.
• Concurrent biological response modifiers (within 3 weeks of study entry) except for any type of erythropoetin.
• Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
• Known allergy or hypersensitivity reactions to aminoglycosides (e.g., kanamycin).
• Known allergy or hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80.
• Previous exposure to murine monoclonal antibody (with HAMA titer above detection limit at baseline) or known hypersensitivity to murine proteins.
• Major surgery within 3 weeks.
• Known history of HIV infection.
• Known chronic Hepatitis B or C.

Please refer to this study by ClinicalTrials.gov identifier  NCT00132379

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
Denmark
      Onkologisk Klinik, Rigshospitalet, Copenhagen,  Denmark
Russian Federation
      St. Petersburg Pavlov State Medical University, St Petersburg,  197089,  Russian Federation
      City Center of Intensive Pulmonogy and Thoracic Surgery, St. Petersburg Miltifield Hospital #2, St Petersburg,  194354,  Russian Federation

Study chairs or principal investigators

Suzanne Kilany,  Study Director,  Active Biotech Research   

Study ID Numbers:  05762003
Last Updated:  August 19, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00132379
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23