Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001572
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Status:
COMPLETED
Status Verified Date:
2010-11-02
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:
Patients undergo chemotherapy until remission is obtained or disease has been stable for two cycles of chemotherapy or progressive disease develops
Three to six months after completion of chemotherapy patients who have achieved complete clinical remission or minimal disease status receive a series of 5 injections given 1-2 months apart of a vaccine consisting of 05 mg autologous tumor-derived immunoglobulin Id conjugated to KLH The vaccine is administered with subcutaneous QS-21 as an immunological adjuvant
Three to six months after completion of chemotherapy patients who have achieved complete clinical remission or minimal disease status receive a series of 5 injections given 1-2 months apart of a vaccine consisting of 05 mg autologous tumor-derived immunoglobulin Id conjugated to KLH The vaccine is administered with subcutaneous QS-21 as an immunological adjuvant
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 objectives of this study are 1 to evaluate feasibility and toxicity of new vaccine formulations and 2 to evaluate cellular and humoral immune responses against the unique idiotype of the patients lymphoma
The goal of this study is to treat patients with follicular lymphomas to complete remission or minimal residual disease with chemotherapy Six to twelve months after completion of chemotherapy in an effort to reduce the relapse rate by eradicating microscopic disease resistant to chemotherapy patients will receive one of two new formulations of an autologous Id vaccine
The objectives of this study are 1 to evaluate feasibility and toxicity of new vaccine formulations and 2 to evaluate cellular and humoral immune responses against the unique idiotype of the patients lymphoma
The goal of this study is to treat patients with follicular lymphomas to complete remission or minimal residual disease with chemotherapy Six to twelve months after completion of chemotherapy in an effort to reduce the relapse rate by eradicating microscopic disease resistant to chemotherapy patients will receive one of two new formulations of an autologous Id vaccine
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 |
|---|---|---|---|
| 97-C-0077 | None | None | None |