Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084799
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2004-06-10
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer SCLC
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer SCLC
PURPOSE This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer SCLC
Detailed Description:
OBJECTIVES
Primary
Determine the targeting tissue distribution and pharmacokinetics of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
Secondary
Determine the immunogenicity of of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
Determine tumor response of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
Determine the safety of tof monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
OUTLINE This is an open-label pilot study
Patients received monoclonal antibody hu3S193 mAb hu3S193 intravenously IV over 30 minutes on day 1 of weeks 1-4 Patients also received indium-111 111In radiolabeled hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging Treatment continued in the absence of disease progression or unacceptable toxicity
Patients were followed at 1 and 4 weeks every 3 months for 1 year and then every 6-12 months thereafter
Primary
Determine the targeting tissue distribution and pharmacokinetics of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
Secondary
Determine the immunogenicity of of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
Determine tumor response of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
Determine the safety of tof monoclonal antibody hu3S193 in patients with progressive small cell lung cancer SCLC
OUTLINE This is an open-label pilot study
Patients received monoclonal antibody hu3S193 mAb hu3S193 intravenously IV over 30 minutes on day 1 of weeks 1-4 Patients also received indium-111 111In radiolabeled hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging Treatment continued in the absence of disease progression or unacceptable toxicity
Patients were followed at 1 and 4 weeks every 3 months for 1 year and then every 6-12 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC 04-012 | OTHER | None | None |
| CDR0000365621 | OTHER | Ludwig Institute for Cancer Research | None |