Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
12

Summary

Conditions
Lymphoplasmacytic Lymphoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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. SECON...

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.

Tracking Information

NCT #
NCT01209871
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sheeba Thomas M.D. Anderson Cancer Center