Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting

Phase 1

Conditions

Lymphoplasmacytic Lymphoma

Treatments

Other: Laboratory Biomarker Analysis

Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01209871

NCI-2012-01897 (Registry Identifier)

NCI-2010-02091

2009-0465 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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