Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

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 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

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