LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

NCT00161239 | Terminated

• 2 other identifiers: 5192CINJ#010410
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

T-Cell Lymphoma

Keywords

T-Cell Lymphomas

Outcome Measures

Primary Outcomes (1)

• Evaluation of specific chemotherapy intervention

Interventions

Doxil, Methotrexate, L-Asparaginase, Prednisone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

liposomal doxorubicin; Methotrexate; Asparaginase; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Roger Strair, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 11, 2009

Record last verified: 2009-12

Locations

US (1)