Clinical Trial: Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase 2 Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas
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 aggr
Detailed 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-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 tumo
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- Maximum Tolerated Dose (MTD) of Alemtuzumab [ Time Frame: Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days. ]MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously every 3 weeks for up to 6 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).
- Number of Participants With Adverse Events [ Time Frame: 67 months and 9 days ]Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: September 17, 2003
Date Started: September 2003
Date Completion: March 2018
Last Updated: August 1, 2016
Last Verified: August 2016
- Maximum Tolerated Dose (MTD) of Alemtuzumab [ Time Frame: Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days. ]
