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Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

Primary Purpose

Lymphoplasmacytic Lymphoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Laboratory Biomarker Analysis
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoplasmacytic Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vaccine therapy)

Arm Description

Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.

Outcomes

Primary Outcome Measures

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
Toxicity type and severity will be summarized by frequency tables.

Secondary Outcome Measures

Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells
The rate of immune response will be estimated.

Full Information

First Posted
September 24, 2010
Last Updated
August 11, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01209871
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 26, 2015 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoplasmacytic Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vaccine therapy)
Arm Type
Experimental
Arm Description
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
Intervention Type
Biological
Intervention Name(s)
Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Intervention Description
Given ID
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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
Description
Toxicity type and severity will be summarized by frequency tables.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells
Description
The rate of immune response will be estimated.
Time Frame
At 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheeba Thomas
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29439670
Citation
Thomas SK, Cha SC, Smith DL, Kim KH, Parshottam SR, Rao S, Popescu M, Lee VY, Neelapu SS, Kwak LW. Phase I study of an active immunotherapy for asymptomatic phase Lymphoplasmacytic lymphoma with DNA vaccines encoding antigen-chemokine fusion: study protocol. BMC Cancer. 2018 Feb 13;18(1):187. doi: 10.1186/s12885-018-4094-2.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

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