Lymphoplasmacytic Lymphoma
Conditions
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.
Interventions
BIOLOGICALAutologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Given ID
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4 weeks | Toxicity type and severity will be summarized by frequency tables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells | At 12 weeks | The rate of immune response will be estimated. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSheeba Thomas
M.D. Anderson Cancer Center
Outcome results
None listed