Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069238
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2003-09-17
Brief Title:
Campath-1H and EPOCH to Treat Non-Hodgkins T- and NK-Cell Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase 2 Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2022-02
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:
Background
The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types
A new class of agents humanized and chimerized monoclonal antibodies typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy It has become clear that in certain lymphomas and breast cancers the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone
The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkin s lymphoma In most reports less than 20 of patients with T cell lymphoid malignancies remain free of disease at 5 years
Objectives
Determine the toxicity of Alemtuzumab and etoposide prednisone vincristine cyclophosphamide doxorubicin EPOCH chemotherapy in untreated cluster of differentiation 52 CD52-expressing T and natural killer NK lymphoid malignancies
Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH chemotherapy
Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab and EPOCH chemotherapy
Eligibility
CD52-expressing lymphoid malignancy
Patients with chemotherapy naive aggressive T NK lymphomas Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible
Age greater than or equal to 17 years
Adequate organ function unless impairment due to respective organ involvement by tumor
No active symptomatic ischemic heart disease myocardial infarction or congestive heart failure within the past year
Human immunodeficiency virus HIV negative
Not pregnant or nursing
Design
Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a preliminary fashion the antitumor activity of the combination with Dose-Adjusted EPOCH
Three dose levels of Alemtuzumab will be explored in cohorts of three to six patients each Patients will receive either 30 60 or 90 mg of Alemtuzumab on day 1 of therapy followed by dose-adjusted EPOCH chemotherapy days 1-5
The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types
A new class of agents humanized and chimerized monoclonal antibodies typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy It has become clear that in certain lymphomas and breast cancers the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone
The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkin s lymphoma In most reports less than 20 of patients with T cell lymphoid malignancies remain free of disease at 5 years
Objectives
Determine the toxicity of Alemtuzumab and etoposide prednisone vincristine cyclophosphamide doxorubicin EPOCH chemotherapy in untreated cluster of differentiation 52 CD52-expressing T and natural killer NK lymphoid malignancies
Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH chemotherapy
Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab and EPOCH chemotherapy
Eligibility
CD52-expressing lymphoid malignancy
Patients with chemotherapy naive aggressive T NK lymphomas Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible
Age greater than or equal to 17 years
Adequate organ function unless impairment due to respective organ involvement by tumor
No active symptomatic ischemic heart disease myocardial infarction or congestive heart failure within the past year
Human immunodeficiency virus HIV negative
Not pregnant or nursing
Design
Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a preliminary fashion the antitumor activity of the combination with Dose-Adjusted EPOCH
Three dose levels of Alemtuzumab will be explored in cohorts of three to six patients each Patients will receive either 30 60 or 90 mg of Alemtuzumab on day 1 of therapy followed by dose-adjusted EPOCH chemotherapy days 1-5
Detailed Description:
Background
The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types
A new class of agents humanized and chimerized monoclonal antibodies typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy It has become clear that in certain lymphomas and breast cancers the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone
The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkins lymphoma In most reports less than 20 of patients with T cell lymphoid malignancies remain free of disease at 5 years
Objective
Determine the toxicity and maximum tolerated dose MTD of Alemtuzumab and EPOCH chemotherapy in untreated cluster of differentiation 52 CD52-expressing T and natural killer NK lymphoid malignancies
Eligibility
CD52-expressing lymphoid malignancy
Patients with chemotherapy naive aggressive T NK lymphomas Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible
Age greater than or equal to 17 years
Adequate organ function unless impairment due to respective organ involvement by tumor
No active symptomatic ischemic heart disease myocardial infarction or congestive heart failure within the past year
Human immunodeficiency virus HIV negative
Not pregnant or nursing
Design
Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a preliminary fashion the antitumor activity of the combination with Dose-Adjusted etoposide prednisone vincristine cyclophosphamide doxorubicin EPOCH
Three dose levels of Alemtuzumab will be explored in cohorts of three to six patients each Patients will receive either 30 60 or 90 mg of Alemtuzumab on day 1 of therapy followed by dose-adjusted EPOCH chemotherapy days 1-5
The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types
A new class of agents humanized and chimerized monoclonal antibodies typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy It has become clear that in certain lymphomas and breast cancers the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone
The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkins lymphoma In most reports less than 20 of patients with T cell lymphoid malignancies remain free of disease at 5 years
Objective
Determine the toxicity and maximum tolerated dose MTD of Alemtuzumab and EPOCH chemotherapy in untreated cluster of differentiation 52 CD52-expressing T and natural killer NK lymphoid malignancies
Eligibility
CD52-expressing lymphoid malignancy
Patients with chemotherapy naive aggressive T NK lymphomas Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible
Age greater than or equal to 17 years
Adequate organ function unless impairment due to respective organ involvement by tumor
No active symptomatic ischemic heart disease myocardial infarction or congestive heart failure within the past year
Human immunodeficiency virus HIV negative
Not pregnant or nursing
Design
Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a preliminary fashion the antitumor activity of the combination with Dose-Adjusted etoposide prednisone vincristine cyclophosphamide doxorubicin EPOCH
Three dose levels of Alemtuzumab will be explored in cohorts of three to six patients each Patients will receive either 30 60 or 90 mg of Alemtuzumab on day 1 of therapy followed by dose-adjusted EPOCH chemotherapy days 1-5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 03-C-0304 | None | None | None |