Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369291
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
2006-08-24
Brief Title:
CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
CPG 7909 Oligodeoxynucleotides ODNS After Autologous Transplantation to Enhance Immune Reconstitution
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving CpG 7909 after an autologous stem cell transplant may make a stronger immune response and prevent or delay the recurrence of cancer
PURPOSE This phase I trial is studying the side effects and best dose of CpG 7909 in treating patients who have undergone autologous stem cell transplant
PURPOSE This phase I trial is studying the side effects and best dose of CpG 7909 in treating patients who have undergone autologous stem cell transplant
Detailed Description:
OBJECTIVES
Primary
Determine whether CpG 7909 enhances immune function as measured by the response to keyhole limpet hemocyanin neo-antigen and tetanus toxoid memory antigen in patients who have undergone autologous stem cell transplantation
Secondary
Determine if dose escalation of CpG 7909 within a range of previously tested safe doses of CpG 7909 impacts upon the primary immune readouts
OUTLINE This is a non-randomized dose-escalation study of CpG 7909
Patients receive CpG 7909 subcutaneously SC on days 1 7 and 14 Patients receive keyhole limpet hemocyanin SC and tetanus toxoid SC on day 7
Cohorts of 3-6 patients receive escalating doses of Cp6 7909 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A total of 10 patients are treated at the MTD
Blood is collected at baseline and at approximately day 40 for immunological studies including immunoenzyme techniques antibody response assays and immunophenotyping
After completion of study treatment patients are followed every 3 months for 1 year
Primary
Determine whether CpG 7909 enhances immune function as measured by the response to keyhole limpet hemocyanin neo-antigen and tetanus toxoid memory antigen in patients who have undergone autologous stem cell transplantation
Secondary
Determine if dose escalation of CpG 7909 within a range of previously tested safe doses of CpG 7909 impacts upon the primary immune readouts
OUTLINE This is a non-randomized dose-escalation study of CpG 7909
Patients receive CpG 7909 subcutaneously SC on days 1 7 and 14 Patients receive keyhole limpet hemocyanin SC and tetanus toxoid SC on day 7
Cohorts of 3-6 patients receive escalating doses of Cp6 7909 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A total of 10 patients are treated at the MTD
Blood is collected at baseline and at approximately day 40 for immunological studies including immunoenzyme techniques antibody response assays and immunophenotyping
After completion of study treatment patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| UMN-MT2003-03 | OTHER | Blood and Marrow Transplantation Program | None |
| UMN-0302M41542 | OTHER | None | None |