Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
Status:
Completed
Trial end date:
2021-06-16
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of an experimental cancer vaccine for
mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although
standard treatments for lymphoma may achieve disease remission, none provides a cure.
Patients with mantle cell lymphoma 18 years and older who have not been treated previously
with chemotherapy may participate in this study. Candidates will be screened for eligibility
with a medical history and physical examination. Other tests that may be required include
blood and urine tests; lung function studies; imaging tests such as magnetic resonance
imaging, computed tomography and X-rays; and biopsy (surgical removal of a small tissue
sample) of tumor, bone marrow, or other tissue.
Patients enrolled in the study will begin treatment with chemotherapy designed to reduce
disease to a minimum that is, to achieve remission or shrink the tumor as much as possible.
Chemotherapy will be administered on an outpatient basis over a period of around 12 to 18
weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide,
doxorubicin and vincristine intravenously through (a vein) on days 1 through 5; and
cyclophosphamide intravenously on day 5. Starting day 6, patients receive no chemotherapy for
16 days. In addition, an antibody called rituximab, which attaches to lymphoma cells and may
increase the effectiveness of the chemotherapy, will be given on day 1 of the cycle. Patients
will also receive a protein called G-CSF starting day 6 of the cycle and continuing until the
white blood cell count recovers or until day 19. G-CSF is naturally produced by bone marrow
and may boost the immune system. The chemotherapy drugs and rituximab are infused through a
vein by means of a lightweight portable pump, which patients are taught how to use. Patients
are also how taught how to give themselves G-CSF injections under the skin, similar to
insulin injections.
The first vaccination will be given at least 3 months after chemotherapy ends and will be
repeated every 4 weeks for a maximum of 5 vaccinations. The vaccinations will be given in the
clinic. Patients will also receive daily injections of GM-CSF, a growth factor naturally
produced by bone marrow that can boost the immune system. These injections will be given the
day of the vaccination and for the next 3 days.
When vaccine therapy is completed, patients who were treated successfully will be followed
with periodic clinic visits for follow-up examinations and tests. Patients in whom the
lymphoma did not disappear entirely or who have a recurrence of disease will be advised of
further treatment possibilities.