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| Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Ortho Biotech Products, L.P. |
|---|---|
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00161239 |
Purpose
Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and refractory diseases that are generally treated with chemotherapy. Despite current treatment modalities, only a subset of patients will be cured by the treatment. In this study, four chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be administered in a combination regimen for patients with relapsed or refractory Peripheral and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown to have activity to lymphomas. The objective of the study is to determine if the combination of these chemotherapy agents results in higher response and cure rates in this patient population. This will be a single institutional study which will included 32 patients in the Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.
| Condition | Intervention |
|---|---|
|
T-Cell Lymphoma |
Drug: Doxil, Methotrexate, L-Asparaginase, Prednisone |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
| Official Title: | LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma |
| Estimated Enrollment: | 64 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | February 2008 |
Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and refractory diseases that are generally treated with chemotherapy. Despite current treatment modalities, only a subset of patients will be cured by the treatment. In this study, four chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be administered in a combination regimen for patients with relapsed or refractory Peripheral and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown to have activity to lymphomas. The objective of the study is to determine if the combination of these chemotherapy agents results in higher response and cure rates in this patient population. This will be a single institutional study which will included 32 patients in the Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion:
Patients must be at least 18 years of age. Histologically confirmed (including immunohistochemistry) diagnosis of T-Cell Lymphoma by skin biopsy or visceral/lymph node biopsy or bone marrow aspirate/biopsy Life expectancy of more than 3 months.
Exclusion:
Uncontrolled diabetes mellitus Active or serious infections uncontrolled with antibiotics Concurrent treatment, radiation or investigational treatment. 5.2.6 Significant underlying cardiac disease, including unstable angina, myocardial infarction less than 6 months before starting study, congestive failure of any cause
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Stephanie Grospe, RN 732-235-8062 | |
| Principal Investigator: Roger Strair, MD | |
| Principal Investigator: | Roger Strair, MD | University of Medicine and Dentistry New Jersey |
More Information
| Study ID Numbers: | 5192, CINJ#010410 |
| Study First Received: | September 8, 2005 |
| Last Updated: | April 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00161239 |
| Health Authority: | United States: Institutional Review Board |
|
T-Cell Lymphomas |
|
Asparaginase Prednisone Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Sezary Syndrome Mycosis Fungoides Doxorubicin Folic Acid |
Mycoses Lymphatic Diseases Lymphoma, T-Cell Methotrexate Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |
|
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
