Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006347
Status:
UNKNOWN
Last Update Posted:
2009-03-03
First Post:
2000-10-04
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Sponsor:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 Anti-CEA Antibody for Relapsed or Refractory Small Cell Lung Cancer SCLC
Status:
UNKNOWN
Status Verified Date:
2003-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer
Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood normal organs and tumors of these patients
Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients
Determine the antibody response of these patients treated with this regimen
Determine the antitumor effects of this treatment regimen in these patients
OUTLINE This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 90Y-hMN-14 Patients are stratified according to prior radiotherapy yes vs no
Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0
Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0
Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity
Patients are followed at 2 4 8 and 12 weeks every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 10-14 months
Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer
Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood normal organs and tumors of these patients
Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients
Determine the antibody response of these patients treated with this regimen
Determine the antitumor effects of this treatment regimen in these patients
OUTLINE This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 90Y-hMN-14 Patients are stratified according to prior radiotherapy yes vs no
Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0
Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0
Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity
Patients are followed at 2 4 8 and 12 weeks every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 10-14 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H00-0064 | None | None | None |
| CMMI-C-057A-99 | None | None | None |