Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001512
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
Status:
COMPLETED
Status Verified Date:
2010-03-05
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:
The idiotype of the immunoglobulin on a given B cell malignancy Id can serve as a clonal marker and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic tumor specific antigen by conjugation to a carrier protein KLH and administration with an emulsion-based adjuvant The goals of vaccine development in the current study are to develop vaccines 1 with improved potency and 2 which are more effective at inducing cell-mediated immune responses The selection of GM-CSF as the immunological adjuvant is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response
The objectives of this study are 1 to evaluate cellular and humoral immune responses against the unique idiotype of the patients lymphoma and 2 to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination polymerase chain reaction amplification of the rearranged bcl-2 oncogene
The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy Three to six months after completion of chemotherapy in an effort to reduce the relapse rate by eradicating microscopic disease resistant to chemotherapy patients will receive an autologous Id vaccine administered in combination with GM-CSF Id-KLH 05 mg is administered subcutaneously GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses patients are randomized to either a high or low dose 500 or 100 microgramsm2
We plan to accrue 42 patients Twenty-nine patients have been enrolled Sixteen patients have entered andor completed the vaccination phase Patients have demonstrated significant lymphoproliferative responses specific for autologous idiotype of a magnitude which is significantly greater than previously observed
The objectives of this study are 1 to evaluate cellular and humoral immune responses against the unique idiotype of the patients lymphoma and 2 to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination polymerase chain reaction amplification of the rearranged bcl-2 oncogene
The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy Three to six months after completion of chemotherapy in an effort to reduce the relapse rate by eradicating microscopic disease resistant to chemotherapy patients will receive an autologous Id vaccine administered in combination with GM-CSF Id-KLH 05 mg is administered subcutaneously GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses patients are randomized to either a high or low dose 500 or 100 microgramsm2
We plan to accrue 42 patients Twenty-nine patients have been enrolled Sixteen patients have entered andor completed the vaccination phase Patients have demonstrated significant lymphoproliferative responses specific for autologous idiotype of a magnitude which is significantly greater than previously observed
Detailed Description:
The idiotype of the immunoglobulin on a given B cell malignancy Id can serve as a clonal marker and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic tumor specific antigen by conjugation to a carrier protein KLH and administration with an emulsion-based adjuvant The goals of vaccine development in the current study are to develop vaccines 1 with improved potency and 2 which are more effective at inducing cell-mediated immune responses The selection of GM-CSF as the immunological adjuvant is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response
The objectives of this study are 1 to evaluate cellular and humoral immune responses against the unique idiotype of the patients lymphoma and 2 to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination polymerase chain reaction amplification of the rearranged bcl-2 oncogene
The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy Three to six months after completion of chemotherapy in an effort to reduce the relapse rate by eradicating microscopic disease resistant to chemotherapy patients will receive an autologous Id vaccine administered in combination with GM-CSF Id-KLH 05 mg is administered subcutaneously GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses
The objectives of this study are 1 to evaluate cellular and humoral immune responses against the unique idiotype of the patients lymphoma and 2 to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination polymerase chain reaction amplification of the rearranged bcl-2 oncogene
The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy Three to six months after completion of chemotherapy in an effort to reduce the relapse rate by eradicating microscopic disease resistant to chemotherapy patients will receive an autologous Id vaccine administered in combination with GM-CSF Id-KLH 05 mg is administered subcutaneously GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 96-C-0133 | None | None | None |