Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00005780|
Recruitment Status : Active, not recruiting
First Posted : June 5, 2000
Last Update Posted : October 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma Lymphoma, Mantle Cell||Drug: EPOCH-R Biological: GM-CSF Biological: Idiotype vaccine||Phase 2|
- 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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||June 1, 2000|
|Actual Primary Completion Date :||August 31, 2005|
|Estimated Study Completion Date :||June 1, 2021|
EPOCH-R followed by idiotype vaccine and GM-CSF
EPOCH-R for 6 cycles
GM-CSF monthly with the vaccine for 5 doses
Biological: Idiotype vaccine
1 injection of vaccine monthly for 5 doses
- Progression-free survival [ Time Frame: Time of Progressive Disease ]The time from start of treatment until disease progression will be calculated.
- response rate of EPOCH-R [ Time Frame: 36 months ]percentage of patients whose cancer shrinks or disappears after treatment with EPOCH-R
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005780
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christopher J Melani, M.D.||National Cancer Institute (NCI)|