Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089076
Status:
TERMINATED
Last Update Posted:
2014-05-30
First Post:
2004-08-04
Brief Title:
MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Anti-CTLA-4 Monoclonal Antibody MDX-010 in B-cell Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2012-12
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:
Biological therapies such as MDX-010 work in different ways to stimulate the immune system and stop cancer cells from growing This phase III trial is studying the side effects and best dose of MDX-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkins lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I To characterize the safety profile of MDX-010 ipilimumab monoclonal antibody and identify a tolerable immunologically active dose level in B cell lymphoma patients
II To evaluate the clinical response rate in B cell lymphoma patients treated with MDX-010
SECONDARY OBJECTIVES
I To evaluate the phenotype and function of memory T cells before and after treatment with MDX-010 by
Quantitation and phenotypic characterization of peripheral blood and tumor infiltrating T-cells including cluster of differentiation CD4CD25 regulatory T cells
Measurement of tumor-specific T cells in peripheral blood lymphocytes
Measuring proliferation of memory T cells in response to recall antigens tetanus toxoid and keyhole limpet hemocyanin KLH
II Measurement of anti-tumor antibodies in serum pre- and post-therapy III To evaluate the time to progression IV To evaluate the duration of response to treatment with MDX-010
OUTLINE This is a multicenter open-label phase I dose-escalation study followed by a phase II study Patients are grouped according to prior treatment with a vaccine therapy for lymphoma yes vs no
PHASE I Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 IV over 90 minutes on day 1 Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients from each group receive escalating doses of MDX-010 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
PHASE II Patients receive MDX-010 as in phase I at the MTD
Patients are followed at 1 and 4 months and then every 6 months for up to 2 years
I To characterize the safety profile of MDX-010 ipilimumab monoclonal antibody and identify a tolerable immunologically active dose level in B cell lymphoma patients
II To evaluate the clinical response rate in B cell lymphoma patients treated with MDX-010
SECONDARY OBJECTIVES
I To evaluate the phenotype and function of memory T cells before and after treatment with MDX-010 by
Quantitation and phenotypic characterization of peripheral blood and tumor infiltrating T-cells including cluster of differentiation CD4CD25 regulatory T cells
Measurement of tumor-specific T cells in peripheral blood lymphocytes
Measuring proliferation of memory T cells in response to recall antigens tetanus toxoid and keyhole limpet hemocyanin KLH
II Measurement of anti-tumor antibodies in serum pre- and post-therapy III To evaluate the time to progression IV To evaluate the duration of response to treatment with MDX-010
OUTLINE This is a multicenter open-label phase I dose-escalation study followed by a phase II study Patients are grouped according to prior treatment with a vaccine therapy for lymphoma yes vs no
PHASE I Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 IV over 90 minutes on day 1 Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients from each group receive escalating doses of MDX-010 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
PHASE II Patients receive MDX-010 as in phase I at the MTD
Patients are followed at 1 and 4 months and then every 6 months for up to 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 |
|---|---|---|---|
| U01CA069912 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069912 |
| NCI-2012-02784 | REGISTRY | None | None |
| MC0312 | OTHER | None | None |
| 6359 | OTHER | None | None |
| P30CA015083 | NIH | None | None |