Clinical Trials Directory

Trials / Completed

CompletedNCT00001572

Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
21 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 0.5 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 patient's 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.

Conditions

Interventions

TypeNameDescription
DRUGId-KLH Vaccine
DRUGQS-21 (Stimulation-QS-21) Drug

Timeline

Start date
1997-01-30
Primary completion
1999-07-31
Completion
2010-11-02
First posted
1999-11-04
Last updated
2017-07-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00001572. Inclusion in this directory is not an endorsement.