Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004048
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
1999-12-10
Brief Title:
Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid 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 Alone or Combined With Doxorubicin and Peripheral Blood Stem Cell Rescue PBSCR in Medullary Thyroid Cancer MTC Grant Application Title Radioimmunotherapy of MTC With Y-90 Humanized MN14 Anti-CEA Mab and Doxorubicin
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 Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy or chemotherapy used to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of radioimmunotherapy with or without doxorubicin plus peripheral stem cell transplantation in treating patients who have thyroid cancer
PURPOSE Phase III trial to study the effectiveness of radioimmunotherapy with or without doxorubicin plus peripheral stem cell transplantation in treating patients who have thyroid cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicities of high dose yttrium Y 90 monoclonal antibody MN-14 with or without doxorubicin plus peripheral blood stem cell rescue in patients with medullary thyroid cancer II Correlate organ and tumor dosimetry with toxicity and antitumor responses in these patients III Assess response and duration of response in these patients after this treatment
OUTLINE This is a dose escalation study of yttrrium Y 90 monoclonal antibody MN-14 90Y-MN-14 Patients are stratified by prior doxorubicin yes vs no Patients receive filgrastim G-CSF subcutaneously SQ on days -11 to -7 and undergo leukapheresis on days -8 to -6 If an adequate number of CD34 cells are not harvested bone marrow is also collected Patients receive pretherapy targeting consisting of indium In 111 monoclonal antibody MN-14 In111-MN-14 on day 0 At least 1 confirmed tumor site must be targeted Patients receive 90Y-MN-14 IV over 30-45 minutes on day 7 Some patients also receive doxorubicin IV on day 8 PBSC or bone marrow is reinfused on approximately day 7-14 Patients also receive G-CSF SQ or IV until blood counts recover Cohorts of 3-6 patients receive escalating radiological doses of 90Y-MN-14 until the maximum tolerated dose MTD is determined The MTD is defined as either the dose at which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold radiation doses to lungs kidneys and liver Patients are followed weekly for the first month monthly for 3 months then every 6 months for up to 5 years
PROJECTED ACCRUAL Approximately 30 patients will be accrued for each stratum of this study within 3 years
OUTLINE This is a dose escalation study of yttrrium Y 90 monoclonal antibody MN-14 90Y-MN-14 Patients are stratified by prior doxorubicin yes vs no Patients receive filgrastim G-CSF subcutaneously SQ on days -11 to -7 and undergo leukapheresis on days -8 to -6 If an adequate number of CD34 cells are not harvested bone marrow is also collected Patients receive pretherapy targeting consisting of indium In 111 monoclonal antibody MN-14 In111-MN-14 on day 0 At least 1 confirmed tumor site must be targeted Patients receive 90Y-MN-14 IV over 30-45 minutes on day 7 Some patients also receive doxorubicin IV on day 8 PBSC or bone marrow is reinfused on approximately day 7-14 Patients also receive G-CSF SQ or IV until blood counts recover Cohorts of 3-6 patients receive escalating radiological doses of 90Y-MN-14 until the maximum tolerated dose MTD is determined The MTD is defined as either the dose at which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold radiation doses to lungs kidneys and liver Patients are followed weekly for the first month monthly for 3 months then every 6 months for up to 5 years
PROJECTED ACCRUAL Approximately 30 patients will be accrued for each stratum of this study within 3 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-V99-1564 | None | None | None |
| CMMI-C-040A-98 | None | None | None |
| CMMI-FDR001555 | None | None | None |