Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

December 1, 2023 updated by: M.D. Anderson Cancer Center

Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (vaccine therapy)
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Given ID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sheeba Thomas, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2015

Primary Completion (Estimated)

February 20, 2024

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimated)

September 27, 2010

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0465 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2012-01897 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • NCI-2010-02091 (Other Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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