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Clinical Trial
. 2013 Apr 2;108(6):1260-6.
doi: 10.1038/bjc.2013.90. Epub 2013 Mar 7.

Phase I clinical trial of human vascular endothelial growth factor receptor 1 peptide vaccines for patients with metastatic renal cell carcinoma

K Yoshimura  1 , T Minami, M Nozawa, H Uemura
Affiliations
Clinical Trial

Phase I clinical trial of human vascular endothelial growth factor receptor 1 peptide vaccines for patients with metastatic renal cell carcinoma

K Yoshimura et al. Br J Cancer. .

Abstract

Background: It is well known that renal cell carcinoma (RCC) represents one of the most immune-responsive cancers. Although the lack of defined antigens in RCC has hindered more specific vaccine development, research regarding vaccination therapy has been of special interest for the treatment of RCC for more than 30 years.

Methods: To evaluate the safety of the vascular endothelial growth factor receptor 1 (VEGFR1) peptide vaccination and its clinical outcomes, data from 18 metastatic RCC (mRCC) patients treated with VEGFR1 vaccine were collected. Toxicity assessments were performed. Clinical outcomes included assessment using CT scanning, magnetic resonance imaging or X-ray examination in accordance with the WHO Response Evaluation Criteria in Solid Tumors.

Results: No patient showed any toxicities of grade 3 or greater. Of the 18 patients, 2 patients showed a partial response during treatment. Stable disease for more than 5 months was observed in eight patients with a median duration of 16.5 months (4-32 months). At the time of the analysis in this study, six patients were alive with a median follow-up of 30 months (26-36 months).

Conclusion: These results suggest that VEGFR1 peptide vaccine is safe and is recommended for further trials for patients with mRCC.

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Figures

Figure 1
Figure 1
Treatment protocol. VEGFR1 vaccine was administered subcutaneously on days 1, 8, 15, and 22 in a 28-day treatment cycle. After evaluation, vaccination was continued every 2 weeks. The amino acid sequences of the two VEGFR1 vaccine are shown. The dose administered was designed in a dose-escalation manner.
Figure 2
Figure 2
Changes of CTL response after vaccination. Significant induction of CTL was observed by VEGFR1 peptide vaccine.
Figure 3
Figure 3
Instance of VEGRF1 vaccine responder. (A) The patient had lung metastases resistant to IFN treatment. Shrinking of lung metastases was noted. (B) The patient had multiple bone metastases resistant to IL-2/IFN/sorafenib treatment. He achieved PR with shrinking of the bone metastatic lesions, and, at present, is stable continuing vaccine treatment.
Figure 4
Figure 4
The entire overall survival curve is indicated with a median OS of 70 weeks.
See this image and copyright information in PMC

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