Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
18 Years
N/A
Both
Lymphoma
Trial Information
Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
The Study Vaccine:
The cancer vaccine used in this study is made from DNA (the genetic material of cells). The
vaccine is designed to increase your immune system's ability to react against
lymphoplasmacytic lymphoma.
Making the Vaccine:
About 4-5 weeks are needed to make this vaccine from your tumor. Although a lot of effort
will be used to try to make the vaccine for each participant, researchers are not always
successful. Researchers cannot and do not guarantee that you will receive a vaccine.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level based on when you start the study. If you are on of the first 6 participants, you
will receive a lower dose of the vaccine. If that dose level is found to be safe, all other
participants will receive a higher dose of vaccine.
Once the vaccine is ready (about 4-5 weeks), you may receive up to 3 vaccines. You will no
longer be able to take the vaccine if the disease gets worse or intolerable side effects
occur. Your participation on this study will be complete 1 year after your last vaccination.
Study Visits:
During the study, you will have the following tests and procedures performed. These tests
and procedures are part of regular cancer care; however, they will be done more often while
you are in this study.
Within 2 days before each vaccine:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) and urine will be collected to check the status of the
disease. This urine will be collected over a 24-hour period. You will be provided
with a container for urine collection.
- Blood (about 2 teaspoons) will be drawn to check for immune system disorders.
On the day you receive your vaccine:
- You will have a physical exam.
- You will be asked how you are feeling.
- You will be asked about any drugs you may be taking.
At 4 and 8 weeks, blood (2 tablespoons) will be drawn to check how your immune system
responds to the vaccines.
At 4 weeks after your last vaccination, blood (about 2 tablespoons) will be drawn to check
how your immune system responds to the vaccines.
About 4 weeks after your last vaccination, and then every 2 month for 1 year:
- Your medical history will be recorded.
- You will have a physical exam.
- You will be asked how you are feeling.
- You will be asked about any drugs you may be taking.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- Blood (about 1 tablespoon) and urine will be collected to check the status of the
disease. This urine will be collected over a 24-hour period. You will be provided with
a container for urine collection.
- Blood (about 2 teaspoons) will be drawn to check for immune system disorders.
About 4 months after your last vaccination, and then every 4 months for 1 year, blood (about
2 tablespoons) will be drawn to check how your immune system responds to the vaccines.
About 4 weeks after your last vaccination, and then every 6 months for 1 year, you will have
a CT scan to check the status of the disease.
This is an investigational study. The vaccine is not FDA approved or commercially
available. It is currently being used for research purposes only.
Up to 12 patients will take part in this study. All patients will be enrolled at MD
Anderson.
Inclusion Criteria:
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 /= 30 ml/min.
7. Total Bilirubin
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.
Exclusion Criteria:
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD)
Outcome Description:
Evaluations at 4 weeks after last vaccination, and every 2 months thereafter for a year.
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Principal Investigator
Sheeba K. Thomas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2009-0465
NCT ID:
NCT01209871
Start Date:
September 2013
Completion Date:
Related Keywords:
- Lymphoma
- Lymphoplasmacytic Lymphoma
- Recombinant DNA
- Fusion DNA Vaccine
- Lymphoma
- Waldenstrom Macroglobulinemia
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
