Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21
The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other foreign substances. The immune system is made up of many different types of cells, which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection given into or under the skin. It is made up of several parts. The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2 is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a snail- like marine mollusk called a keyhole limpet and has been used for many years to boost immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called QS21, from the bark of a tree, which also helps the immune system to make more cancer- fighting cells. A vaccine like the one you will receive has been given to laboratory animals and been shown to produce an immune response in these animals.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing MUC-2-KLH Doses|
- To determine an optimal dose of the MUC-2-KLH conjugate plus the immunological adjuvant QS21 in patient with prostate cancer that Induces an antibody response to MUC-2. and induces helper T and/or cytotoxic T cell response against MUC -2. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
- To determine the safety of immunization with MUC-2-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
- To determine the effect of MUC-2-KLH dose on the T cell response against MUC-2 and by skin testing. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- To assess post-immunization changes in prostate specific antigen levels and other objective parameters or disease (radionuclide bone scan and/or measurable disease if present). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- To monitor changes in serum CASA levels prior to and following treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- To monitor sequentially, the peripheral blood for the presence of PSA mRNA in circulating cells using a PCR based assay. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 1997|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Three groups of 5 patients enrolled sequentially comprised from will receive MUC-2-KLH vaccines at the following g amounts of MUC-2-KLH per vaccination.
10 + 100 μg QS21 30 + 100 μg QS21 3 + 100 μg QS21
The MUC-2-KLH conjugate will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4 week break and then a fourth vaccination during week 7, and 3 months later during week 19. Booster vaccinations may be given at or after week 50 and 100, and every 6 months thereafter to select patients who show no evidence of radiographic disease progression.
After 5 patients have been enrolled and completed two vaccinations without Grade II or greater toxicity, we will proceed to the next higher dose level. No dose escalations will be performed in the same patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698711
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Susan Slovin, MD,PhD||Memorial Sloan Kettering Cancer Center|