Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005780
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2000-06-03
Brief Title:
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 granulocyte colony-stimulating factor 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 granulocyte-macrophage colony-stimulating factor 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
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 granulocyte colony-stimulating factor 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 granulocyte-macrophage colony-stimulating factor 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
Detailed Description:
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 etoposide prednisone vincristine cyclophosphamide doxorubicin and rituximab EPOCH-Ridiotype 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 biopsyharvest or greater than 1000microl of circulating tumor cells in the blood
Eastern Cooperative Oncology Group 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 study is closed as of 4182022
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 etoposide prednisone vincristine cyclophosphamide doxorubicin and rituximab EPOCH-Ridiotype 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 biopsyharvest or greater than 1000microl of circulating tumor cells in the blood
Eastern Cooperative Oncology Group 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 study is closed as of 4182022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0133 | None | None | None |