Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)
Source: ClinicalTrials.gov NCT00084799 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmation of Tumor Targeting as Measured by the Number of Patients With Assessable Lesions Greater Than or Equal to 2 cm Measured by FDG-PET and SPECT Imaging. |
5; 5 | — |
| SECONDARY Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity |
13.28; 7.45; 126.22; 129.60 | — |
| SECONDARY Mean Volume of Distribution of Central Compartment (V1) as Measured by 111In-hu3S193 Radioactivity |
3040.78; 3468.07 | — |
| SECONDARY Mean Clearance (CL) as Measured by 111In-hu3S193 Radioactivity |
28.83; 30.81 | — |
| SECONDARY Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 Radioactivity |
859.97; 1327.00 | — |
| SECONDARY Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193. |
0; 0; 5; 5 | — |
| SECONDARY Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Small cell lung cancer, pathologically confirmed. Measurable disease, including at least one lesion measuring ≥ 2 cm that has not been previously irradiated.
Progression of disease after one, two, or three prior chemotherapy regimens. At least 4 weeks since the last chemotherapy or radiation treatment. Karnofsky performance status ≥ 70% (ECOG 0 or 1).
The following laboratory results within the last 2 weeks prior to study day 1:
White Blood Cell Count (WBC) ≥ 3,500/mm3; Platelet count ≥ 100 x 10^9/L; Serum creatinine ≤ 2.0 mg/dL; Serum bilirubin ≤ 2.0 mg/dL; International normalized ratio (INR) ≤ 1.3; Women of childbearing potential with confirmed negative quantitative serum HCG on the day of administration of study agent.
Negative stool guaiac test (read by laboratory). Tumor tissue positive for Lewis Y expression.
Exclusion Criteria
Clinically significant cardiac disease (New York Heart Association Class III/IV).
Uncontrolled brain or leptomeningeal metastases. GI bleed within the preceding 6 months. Patients with history of receiving mouse monoclonal antibody. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
Women who are pregnant or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT00084799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.