Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT01209871|
Recruitment Status : Active, not recruiting
First Posted : September 27, 2010
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoplasmacytic Lymphoma||Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine Other: Laboratory Biomarker Analysis||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion|
|Actual Study Start Date :||February 26, 2015|
|Estimated Primary Completion Date :||February 20, 2020|
|Estimated Study Completion Date :||February 20, 2020|
Experimental: Treatment (vaccine therapy)
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0 [ Time Frame: 4 weeks ]Toxicity type and severity will be summarized by frequency tables.
- Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells [ Time Frame: At 12 weeks ]The rate of immune response will be estimated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209871
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sheeba Thomas||M.D. Anderson Cancer Center|