Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma with DNA Vaccines Encoding Antigen-Chemokine Fusion
Fusion DNA Vaccine
Sheeba K. Thomas
The goal of this clinical research study is to find the highest tolerable dose of a cancer vaccine that can be given to patients with asymptomatic lymphoplasmacytic lymphoma (LPL). The safety of this vaccine is also being studied.
Disease Group: Lymphoma
Treatment Agent: Fusion DNA Vaccine
Treatment Location: Only at MDACC
Estimatated Length of Stay in Houston: No hospitalization required.
Return Visit: Patients will receive 3 vaccinations at 4-week intervals (+/- 3 business days). There will be a follow-up visit 4 weeks post vaccination and every 2 months for one year.
Home Care: none
Primary To evaluate the safety and feasibility of using a novel lymphoma DNA vaccine encoding MIP3á-fused lymphoma idiotype in single chain format. To determine the maximum tolerated dose (MTD) of the vaccine. Secondary To assess the immunogenicity of the vaccine to generate tumor-specific cellular and humoral immune responses.
IRB Review and Approval Date: 02/26/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Age >/= 18 years
2) Tissue diagnosis of Lymphoplasmacytic Lymphoma with surface IgG, IgA or 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)
3) Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
4) Patients must provide a lymph node sample of at least 1.5cm in the long axis, or a bone marrow aspiration sample providing at least 5 million CD20 and/or CD38+ (approximately 10 ml)
5) ECOG performance status of 0 or 1
6) Serum creatinine </= 1.5 mg/dl and a Creatinine clearance >/= 30 ml/min.
7) Total Bilirubin </= 1.5 mg/dl unless felt secondary to Gilbert’s disease and AST/ALT </= 2 x upper limit of normal
8) Ability to provide informed consent, and to return to clinic for adequate follow-up for the period that the protocol requires
9) 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.
10) Male subject agrees to use an acceptable method for contraception for the duration of the study.
1) HIV, Hepatitis B and/or Hepatitis C infection
2) Pregnancy or lactating females
3) 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
4) Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
5) Patients with New York Heart Association Class 3 or 4 disease
6) Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
7) Patients with positive ANA and/or anti-dsDNA antibodies
Information and next steps
Sheeba K. Thomas
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