Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21
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|ClinicalTrials.gov Identifier: NCT00698711|
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : January 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: MUC-2-KLH||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing MUC-2-KLH Doses|
|Study Start Date :||November 1997|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
- 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 ]
- To determine the safety of immunization with MUC-2-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21. [ Time Frame: conclusion of study ]
- 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 ]
- 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 ]
- To monitor changes in serum CASA levels prior to and following treatment. [ Time Frame: conclusion of study ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|