Brief Title
Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
Official Title
Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells
Condition
Lymphoplasmacytic Lymphoma
Intervention
Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Study Arms / Comparison Groups
Treatment (vaccine therapy)
Description: Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
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
Biological
Estimated Enrollment
9
Start Date
February 26, 2015
Completion Date
February 20, 2024
Primary Completion Date
February 20, 2024
Eligibility Criteria
Inclusion Criteria: - Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC) - Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase - Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Serum creatinine =< 1.5 mg/dl and a creatinine clearance >= 30 ml/min - Total bilirubin =< 1.5 mg/dl unless felt secondary to Gilbert's disease - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal - Ability to provide informed consent, and to return to clinic for adequate follow-up for the period that the protocol requires - Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 30 days after the last vaccination has been administered - Male subject agrees to use an acceptable method for contraception for the duration of the study Exclusion Criteria: - Human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C infection - Pregnancy or lactating females - Patients with previous history of malignancy within the last 5 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in-situ of other organs - Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment - Patients with New York Heart Association class 3 or 4 disease - Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis - Patients with positive antinuclear antibody (ANA) and/or anti-double strand (ds) DNA antibodies
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sheeba Thomas, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01209871
Organization ID
2009-0465
Secondary IDs
NCI-2012-01897
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Sheeba Thomas, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
March 2023