Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007956
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-01-06
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22 B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2002-02
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 Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen
Determine the pharmacokinetic profile of this drug in these patients
Correlate the pharmacokinetic parameters with the biologic effects andor toxicity of this drug in these patients
Determine whether clinical responses in these patients occur at lower equal or higher doses than historical responses induced by a similar drug
OUTLINE This is a dose-escalation study Patients are stratified according to number of circulating tumor cells in peripheral blood more than 50mm3 vs 50mm3 or less
Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1 3 and 5 Patients achieving complete partial or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 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 achieving complete remission or stable partial remission are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study within 12-18 months
Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen
Determine the pharmacokinetic profile of this drug in these patients
Correlate the pharmacokinetic parameters with the biologic effects andor toxicity of this drug in these patients
Determine whether clinical responses in these patients occur at lower equal or higher doses than historical responses induced by a similar drug
OUTLINE This is a dose-escalation study Patients are stratified according to number of circulating tumor cells in peripheral blood more than 50mm3 vs 50mm3 or less
Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1 3 and 5 Patients achieving complete partial or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 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 achieving complete remission or stable partial remission are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTSMC-99-02-07 | None | None | None |
| NCI-01-C-0021 | None | None | None |