NCT01209871

Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and feasibility of using a novel lymphoma deoxyribonucleic acid (DNA) vaccine encoding macrophage inflammatory protein 3 alpha (MIP3a)-fused lymphoma idiotype in single chain format. II. To determine the maximum tolerated dose (MTD) of the vaccine. SECONDARY OBJECTIVES: I. To assess the immunogenicity of the vaccine to generate tumor-specific cellular and humoral immune responses. OUTLINE: This is a dose-escalation study. Patients receive autologous lymphoma immunoglobulin-derived single-chain variable fragment (scFV)-chemokine DNA vaccine intradermally (ID) at 0, 4, and 8 weeks. After completion of study treatment, patients are followed up at 4 weeks, and then every 6 months for 1 year.

Conditions

• Lymphoplasmacytic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine	Given ID
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2015-02-26
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2010-09-27
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study