Trial Information

A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal, or Peritoneal Cancer

The primary endpoint will be to determine the safety and feasibility of administering
ovarian cancer peptides to women who have undergone debulking surgery and systemic
chemotherapy, with the secondary objectives of evaluating immune response as measured by
ELISPOT to the immunizations, to compare the immune response as measured by ELISPOT achieved
by the two different dosing strategies and to assess disease relapse survival. Two cohorts
of 9 patients each will be treated with different doses of the OCPM vaccine. They will
receive the peptide vaccine subcutaneously on weeks 0,1,2,3,5 and6 and then receive the
immunizations every 1 month for 6 months or disease recurrence. The first 9 patients will be
entered into the first cohort; if 1 or fewer patients experience Dose-limiting toxicity
(DLT) then the next 9 will be enrolled into the second cohort. DLT is defined as any Grade
3 or greater hematologic or non-hematologic toxicity or autoimmune disease (except for
fever, skin reaction, or alopecia which would be grade 4) occurring at any time from the
first immunization until 30 days after the last immunization. Toxicity will be assessed at
each dose level using CTC toxicity criteria. Ovarian cancer peptide-specific immune response
will be measured by ELISpot. Time to disease relapse will be based on composite assessment
of clinical signs, objective exam findings, radiologic imaging, and CA125 results. A dosing
scheme will be considered safe if <1 of the first 9 subjects treated at a dose level
experience DLT (as described above). A subject will be considered evaluable for safety if
treated with at least one immunization. A T cell response will be considered positive by
ELISpot if: the mean number of spots in six wells with antigen exceeds the number of spots
in six control wells by 10 and the difference between single values of the six wells
containing antigen and the six control wells is statistically significant at a level of p ≤
0.05 using Student's t test.