Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047164
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2002-10-03
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Ipilimumab MDX-CTLA4 MDX-010 in Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy
PURPOSE This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma colon cancer or prostate cancer refractory to vaccine therapy part I prostate cancer and mantle cell lymphoma closed to accrual as of 3102005 colon cancer closed to accrual as of 92805
Determine the toxicity of this drug at escalating doses in patients with follicular lymphoma part II
Determine the toxicity of this drug at escalating doses in patients with non-Hodgkins lymphoma or Hodgkins lymphoma part III
Secondary
Determine the ability of this drug to increase tumor-specific T-cell responses in these patients
Determine the ability of this drug to produce clinical tumor response in these patients
Determine the effect of this drug on suppressor T-cell populations CD4 and CD25 cells in these patients
OUTLINE This is a pilot partial dose-escalation study
Part I patients with prostate or colon cancer or follicular or mantle cell lymphomas prostate cancer and mantle cell lymphoma closed to accrual as of 3102005 colon cancer closed to accrual as of 92805 Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4 IV over 90 minutes on day 1 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Part II dose-escalation patients with follicular lymphomas only Patients receive MDX-CTLA4 as in part I Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Part III dose-escalation patients with non-Hodgkins or Hodgkins lymphoma Patients receive MDX-CTLA4 as in part II
NOTE No dose-escalation for lymphoma patients who have previously been treated with an allogeneic stem cell transplantation
Patients are followed every other month
PROJECTED ACCRUAL A total of 89 patients will be accrued for this study
Primary
Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma colon cancer or prostate cancer refractory to vaccine therapy part I prostate cancer and mantle cell lymphoma closed to accrual as of 3102005 colon cancer closed to accrual as of 92805
Determine the toxicity of this drug at escalating doses in patients with follicular lymphoma part II
Determine the toxicity of this drug at escalating doses in patients with non-Hodgkins lymphoma or Hodgkins lymphoma part III
Secondary
Determine the ability of this drug to increase tumor-specific T-cell responses in these patients
Determine the ability of this drug to produce clinical tumor response in these patients
Determine the effect of this drug on suppressor T-cell populations CD4 and CD25 cells in these patients
OUTLINE This is a pilot partial dose-escalation study
Part I patients with prostate or colon cancer or follicular or mantle cell lymphomas prostate cancer and mantle cell lymphoma closed to accrual as of 3102005 colon cancer closed to accrual as of 92805 Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4 IV over 90 minutes on day 1 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Part II dose-escalation patients with follicular lymphomas only Patients receive MDX-CTLA4 as in part I Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Part III dose-escalation patients with non-Hodgkins or Hodgkins lymphoma Patients receive MDX-CTLA4 as in part II
NOTE No dose-escalation for lymphoma patients who have previously been treated with an allogeneic stem cell transplantation
Patients are followed every other month
PROJECTED ACCRUAL A total of 89 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000257563 | None | None | None |
| 02-C-0284 | None | None | None |
| NCI-5744 | None | None | None |