A gynecologic oncology group phase II trial of two p53 peptide vaccine approaches: subcutaneous injection and intravenous pulsed dendritic cells in high recurrence risk ovarian cancer patients

Percentage of progression vs survival

Percentage of progression vs survival

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Summary

This study describes the immune response elicited by two vaccine approaches using the wild-type (wt) p53 vaccine. The founding suggest that using either vaccination approach generates comparable specific immune responses against the p53 peptide with minimal toxicity. Accordingly, the findings suggest that the use of less demanding SC approach may be as effective.

Patients characteristics

21 patients were at least 18 years of age with history of stage III, IV or recurrent Ovarian carcinoma.

Methodology

• All patients underwent apheresis 5-7 days prior to the initial vaccination
• Lymphocyte and monocyte derived fractions were cultured in IL-4 and GM-CSF
• On day 4-5 of culture, human CD40 ligand was then added to induce DC maturation.
• The culture was harvested on days 5-6
• The p53 peptide was then added to DC at a concentration of 40-50 uM for 2
hours and the cells were centrifuged and washed
• The final preparation of peptide pulse DC for infusion prepared by resuspending 2×107 cells/mL of the peptide-pulsed cells in a vial.

Treatment

Patients divided into 2 groups.

Results

Arm A, 14 patients received wt p53 peptide with GM-CSF and Montanide ISA- 51 Subcutaneously (SC)
Arm B, 7 patients received 2×107 DC pulsed with wt p53 peptide via slow Intravenously (IV) infusion over 5 minutes All patients on both Arm received the vaccine every 3 weeks for a total of 4 doses.
Side effects in both Arms were comparable. No acute allergic reaction occurred in either of the treatment Arm.
• In Arm A, patients received a total of 143 vaccines experienced grade 1 or grade 2 toxicities.
• In Arm B, patients received total of 68 vaccines ,85% of patients experienced grade1 or grade 2 toxicities in 44% of vaccine, grade 3 toxicities occurred in 5 (23%) patients.
• In Arm B, 2 patients electively terminated therapy both had no evidence of disease (NED) after receiving 14 and 8 vaccines,
• There was no significant differences between the 2 arms in median OS (40.8 months vs 29.6 months), median progression-free survival (PFS) 4.2 months vs 8.7 months.
• The PFS and the overall survival (OS) for the whole group of 20 patients were 5.5 months and 40.4 months.

Conclusion

This shows that using either vaccination approach generates comparable specific immune responses against the p53 peptide with minimal toxicity.

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Scientific article publishing date 9/17/2011

Immucura identifier BSC21_307EN

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