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Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

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ClinicalTrials.gov Identifier: NCT01209871
Recruitment Status : Active, not recruiting
First Posted : September 27, 2010
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lymphoplasmacytic Lymphoma Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine Other: Laboratory Biomarker Analysis Phase 1

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  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
Actual Study Start Date : February 26, 2015
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : February 20, 2020


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

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209871


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sheeba Thomas M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01209871     History of Changes
Other Study ID Numbers: 2009-0465
NCI-2012-01897 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-2010-02091
2009-0465 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Vaccines
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs