LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Brief Title

LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Official Title

LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Brief Summary

      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.

Detailed Description

      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.

Study Type

Interventional

Primary Outcome

Evaluation of specific chemotherapy intervention

Condition

T-Cell Lymphoma

Intervention

Doxil, Methotrexate, L-Asparaginase, Prednisone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

February 2005

Completion Date

October 2007

Primary Completion Date

October 2007

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Roger Strair, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00161239

Organization ID

Secondary IDs

CINJ#010410

Study Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

 Ortho Biotech, Inc.

Study Sponsor

Roger Strair, MD, Principal Investigator, Rutgers, The State University of New Jersey

Verification Date

December 2009