Status:
ACTIVE_NOT_RECRUITING
Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoplasmacytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 idi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01209871
Start Date
February 26 2015
End Date
February 20 2026
Last Update
November 7 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030