Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 5/18/2018 |
| Start Date: | September 19, 2003 |
| End Date: | January 1, 2020 |
Phase 2 Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas
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.
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.
- ELIGIBILITY CRITERIA:
Cluster of differentiation 52 (CD52)-expressing lymphoid malignancy, confirmed by pathology
or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, National
Cancer Institute (NCI). Patients with T & natural killer (NK) cell malignancy without
accessible tissue for flow cytometry analysis may be treated on this study.
Patients with chemotherapy naive aggressive T & NK lymphomas, including but not limited to
peripheral T cell lymphoma (not otherwise specified (nos)), gamma-delta hepatosplenic T
cell lymphoma, subcutaneous panniculitis-like T cell, NK-T cell lymphoma confirmed by
pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology,
NCI. 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.
Laboratory tests: Creatinine less than or equal to 1.5 mg/dL or creatinine clearance
greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to Gilbert's,
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3
times upper limit of normal (ULN) (AST and ALT is less than or equal to 6 times ULN for
patients on hyperalimentation for whom these abnormalities are felt to be due to the
hyperalimentation) and; absolute neutrophil count (ANC) is greater than or equal to
1000/mm(3), platelet greater than or equal to 75,000/mm(3); 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, because of the unknown effects of combined
therapy with chemotherapy and an immunosuppressive agent on HIV progression.
Signed informed consent.
Willing to use contraception.
Not pregnant or nursing, because of the unknown effects of Alemtuzumab on the developing
fetus and infant.
No serious underlying medical condition or infection that would contraindicate treatment.
Patients with central nervous system (CNS) involvement are eligible for treatment on this
study.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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