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Clinical Trial
. 2014 Jun;37(3):261-5.
doi: 10.1097/COC.0b013e318277d5c8.

Randomized phase II study of IL-2 with or without an allogeneic large multivalent immunogen vaccine for the treatment of stage IV melanoma

Gautam Jha  1 , Jeffrey S Miller, Julie M Curtsinger, Yan Zhang, Mathew F Mescher, Arkadiusz Z Dudek
Affiliations
Clinical Trial

Randomized phase II study of IL-2 with or without an allogeneic large multivalent immunogen vaccine for the treatment of stage IV melanoma

"V体育2025版" Gautam Jha et al. Am J Clin Oncol. 2014 Jun.

Abstract

Objective: To evaluate the activity of interleukin-2 (IL-2) in combination with allogeneic large multivalent immunogen (LMI) vaccine, prepared by immobilizing SK23-CD80 melanoma cell line plasma membrane on 5-μm-diameter silica beads, in patients with melanoma VSports手机版. .

Methods: Twenty-one patients with metastatic melanoma were randomly assigned to an IL-2 alone control group or an IL-2 plus LMI vaccine treatment group. The primary objective was to evaluate the progression-free survival (PFS) of each group. Secondary clinical objectives included median overall survival (OS) and 1- and 2-year rates of OS V体育安卓版. .

Results: Treatment was very well tolerated. Median PFS was no different between the treatment arm (2. 20 mo) and control arm (1. 95 mo). Median OS was also similar for the treatment arm (11. 89 mo) and control arm (9. 97 mo). V体育ios版.

Conclusions: This study failed to demonstrate that allogeneic LMI vaccine and low-dose IL-2 improved survival in patients with melanoma as compared with low-dose IL-2 alone VSports最新版本. .

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Conflict of interest statement (V体育平台登录)

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier curves of progression-free survival for the 2 treatment arms.
Figure 2
Figure 2
Kaplan-Meier curves of overall survival for the 2 treatment arms.
See this image and copyright information in PMC

References

    1. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517–2526. - PubMed
    1. Sparano JA, Fisher RI, Sunderland M, et al. Randomized phase III trial of treatment with high-dose interleukin-2 either alone or in combination with interferon alfa-2a in patients with advanced melanoma. J Clin Oncol. 1993;11:1969–1977. - PubMed
    1. Creagan ET, Ahmann DL, Frytak S, et al. Three consecutive phase II studies of recombinant interferon alfa-2a in advanced malignant melanoma. Updated analyses. Cancer. 1987;59(suppl):638–646. - PubMed
    1. Chi M, Dudek AZ. Vaccine therapy for metastatic melanoma: systematic review and meta-analysis of clinical trials. Melanoma Res. 2011;21:165–174. - PubMed (VSports app下载)
    1. Mescher MF. Surface contact requirements for activation of cytotoxic T lymphocytes. J Immunol. 1992;149:2402–2405. - PubMed

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