Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
Nine subjects will participate in this Phase I study that is designed to evaluate the safety
and biology of class I and class II NY-ESO-1/LAGE-1 vaccine with an intent to offer a
therapeutic advantage. The treatment cycle is 6 subcutaneous injections administered every
other week for 12 weeks of NY-ESO-1/LAGE-1 vaccine (weeks 1, 3, 5, 7, 9, 11 (±3 days)). The
vaccinations will be given in the upper arm region, in a volume of 1 milliliter. The dose
will be 1000 mcg of peptide (1 mg). Patients will be evaluated for clinical/immunological
responses at weeks 5 and 11. The vaccine schedule is similar to that of many prior peptide
vaccine studies, in which the schedule was based on earlier animal studies but empirically
derived in human studies (32-34, 36-39).
The first patients will be enrolled to receive subcutaneous vaccination with either class I
or II NY-ESO-1/ LAGE-1 peptide (1000 mcg). Thus, the trial will test the toxicity of the
vaccine with 3 patients in each of 2 vaccine groups, one receiving Class I (group I) and the
other Class II peptide (group II). If no significant toxicity is observed after a treatment
cycle of 12 weeks, then three patients will receive a combination of both peptides (group
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Progressive disease is a new bone lesion on bone scan, progression of nodal or soft tissue, or a 50% increase in prostate specific antigen (PSA) level from the nadir PSA level confirm twice and measured at least two weeks apart.
Tumor evaluation assessment will be performed prior to vaccine 1 (week 1) and every 12 weeks.
Teresa G. Hayes, M.D., Ph.D.
Baylor College of Medicine
United States: Food and Drug Administration
|Baylor College of Medicine/Scott Department of Urology||Houston, Texas 77030|