Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 2/24/2019 |
| Start Date: | June 1, 2000 |
| End Date: | June 1, 2020 |
Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma
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.
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.
Background:
- Mantle cell lymphoma presents a particular clinical challenge because it is aggressive
and incurable with chemotherapy. Thus, novel treatment approaches are needed.
- In follicular center cell lymphomas, another incurable disease, recent evidence suggests
that molecular complete remissions may be achieved following idiotype vaccination in
patients who have achieved minimal residual disease with combination chemotherapy.
- These results suggest that idiotype vaccines may be able to induce a clinically
significant immune response against lymphoma.
Objectives:
- To assess if EPOCH-R/idiotype vaccination is associated with a median progression-free
survival consistent with 36 months;
- To assess if rituximab affects generation of T-cell immunity against the idiotype.
- To compare T-cell immunity using two different methods of isolating the idiotype
protein.
Eligibility:
- Tissue diagnosis of mantle cell lymphoma.
- Age greater than or equal to 18 years.
- Previously untreated with cytotoxic chemotherapy. All stages of disease.
- Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater
than 1000/microl of circulating tumor cells in the blood.
- ECOG performance status less than or equal to 3.
Design:
- In the present study, we propose to investigate the efficacy of idiotype vaccine
treatment in previously untreated patients with mantle cell lymphomas. In order to
achieve minimal residual disease, patients will receive 6 cycles EPOCH chemotherapy and
rituximab (EPOCH-R) followed by 5 idiotype vaccine injections.
- This study has completed accrual of 26 patients and is only open for follow-up.
- Mantle cell lymphoma presents a particular clinical challenge because it is aggressive
and incurable with chemotherapy. Thus, novel treatment approaches are needed.
- In follicular center cell lymphomas, another incurable disease, recent evidence suggests
that molecular complete remissions may be achieved following idiotype vaccination in
patients who have achieved minimal residual disease with combination chemotherapy.
- These results suggest that idiotype vaccines may be able to induce a clinically
significant immune response against lymphoma.
Objectives:
- To assess if EPOCH-R/idiotype vaccination is associated with a median progression-free
survival consistent with 36 months;
- To assess if rituximab affects generation of T-cell immunity against the idiotype.
- To compare T-cell immunity using two different methods of isolating the idiotype
protein.
Eligibility:
- Tissue diagnosis of mantle cell lymphoma.
- Age greater than or equal to 18 years.
- Previously untreated with cytotoxic chemotherapy. All stages of disease.
- Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater
than 1000/microl of circulating tumor cells in the blood.
- ECOG performance status less than or equal to 3.
Design:
- In the present study, we propose to investigate the efficacy of idiotype vaccine
treatment in previously untreated patients with mantle cell lymphomas. In order to
achieve minimal residual disease, patients will receive 6 cycles EPOCH chemotherapy and
rituximab (EPOCH-R) followed by 5 idiotype vaccine injections.
- This study has completed accrual of 26 patients and is only open for follow-up.
- INCLUSION CRITERIA:
Tissue diagnosis of mantle cell lymphoma (confirmed in Laboratory of Pathology). Blastic
cell variant will be eligible.
Age greater than or equal to 18.
Previously untreated with cytotoxic chemotherapy. Patients may have received local
radiation or a short course of steroids for control of symptoms.
All stages of disease.
Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than
1000/microliters of circulating tumor cells in the blood.
ECOG performance status of less than or equal to 3.
Adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater
than 60 ml/min; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients
with Gilbert's syndrome as defined by greater than 80% unconjugated; ANC greater than 1000
and platelets greater than 100,000) unless impairment due to organ involvement by lymphoma.
No active symptomatic ischemic heart disease, myocardial infarction or congestive heart
failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.
Ability to give informed consent.
EXCLUSION CRITERIA:
Antibodies to HIV or presence of hepatitis B surface antigen.
Pregnant or lactating.
Prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively
treated in situ of the cervix.
Involvement of central nervous system by lymphoma.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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