Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004087
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
1999-12-10
Brief Title:
Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Colorectal Cancer or Pancreatic Cancer
Sponsor:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Organization:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Study Overview
Official Title:
Phase III Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Metastatic Colorectal Cancer and Pancreatic Cancers Using Autologous Peripheral Blood Stem Cell Rescue PBSCR to Control Myelotoxicity
Status:
COMPLETED
Status Verified Date:
2011-06
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 Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody plus peripheral stem cell transplantation in treating patients who have metastatic or recurrent colorectal cancer or pancreatic cancer that has not responded to previous treatment
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody plus peripheral stem cell transplantation in treating patients who have metastatic or recurrent colorectal cancer or pancreatic cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and secondary organ toxicity of high dose yttrium Y 90 monoclonal antibody MN-14 90Y-hMN-14 plus autologous peripheral blood stem cell rescue in patients with metastatic or recurrent colorectal or pancreatic cancer II Compare the tumor to organ dose ratio between 90Y-hMN-14 and iodine 131 monoclonal antibody MN-14 131I-MN-14 in these patients III Determine the antitumor effects with myeloablative doses of 90Y-hMN-14 IV Evaluate the immunogenicity of 90Y-hMN-14 in these patients
OUTLINE This is a dose escalation of yttrium Y 90 monoclonal antibody MN-14 90Y-hMN-14 multicenter study Patients are stratified by prior radiotherapy yes vs no Patients receive filgrastim G-CSF subcutaneously on days -18 to -14 and peripheral blood stem cell PBSC collection on days -15 to -13 If an adequate number of CD34 cells are not harvested bone marrow is also collected Patients receive pretherapy imaging with indium In 111 monoclonal antibody MN-14 IN111-MN-14 IV on days -7 to 0 Patients receive 90Y-hMN-14 for up to 40 minutes on day 0 PBSC are reinfused on days 7 to 14 Patients receive G-CSF SQ until blood counts recover 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 at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed at 1-4 6 8 12 and 24 weeks and then every 6 months thereafter for up to 5 years
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within 2 years
OUTLINE This is a dose escalation of yttrium Y 90 monoclonal antibody MN-14 90Y-hMN-14 multicenter study Patients are stratified by prior radiotherapy yes vs no Patients receive filgrastim G-CSF subcutaneously on days -18 to -14 and peripheral blood stem cell PBSC collection on days -15 to -13 If an adequate number of CD34 cells are not harvested bone marrow is also collected Patients receive pretherapy imaging with indium In 111 monoclonal antibody MN-14 IN111-MN-14 IV on days -7 to 0 Patients receive 90Y-hMN-14 for up to 40 minutes on day 0 PBSC are reinfused on days 7 to 14 Patients receive G-CSF SQ until blood counts recover 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 at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed at 1-4 6 8 12 and 24 weeks and then every 6 months thereafter for up to 5 years
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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 |
|---|---|---|---|
| NCI-V99-1571 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA054425 |
| P01CA054425 | NIH | None | None |
| CMMI-C-033-98 | None | None | None |
| NCI-H99-0042 | None | None | None |