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Patient survival on the dose escalation phase of the Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG) clinical trial compared to historical controls.

Publication ,  Conference
Desjardins, A; Sampson, JH; Peters, KB; Vlahovic, G; Randazzo, D; Threatt, S; Herndon, JE; Boulton, S; Lally-Goss, D; McSherry, F; Lipp, ES ...
Published in: Journal of Clinical Oncology
May 20, 2016

Background: The live attenuated oral (SABIN) serotype 1 poliovirus vaccine was modified to contain a heterologous internal ribosomal entry site stemming from human rhinovirus type 2, creating PVSRIPO. PVSRIPO recognizes CD155, an oncofetal cell adhesion molecule and tumor antigen widely expressed ectopically in malignancy. We report the survival results of the dose-finding portion evaluating PVSRIPO delivered intratumorally by convection-enhanced delivery (CED) compared to a historical control group of patients (pts) treated at Duke. Methods: Eligible pts on trial were adults with recurrent supratentorial WHO grade IV MG; solitary tumor 1-5cm in diameter; ≥ 4 weeks after chemotherapy, bevacizumab or study drug; adequate organ function; KPS ≥ 70%; and positive anti-polio titer. A historical group of adult recurrent WHO grade IV mg pts treated at Duke between 1/01/07-12/15/14 was retrospectively identified based on presence of a solitary tumor 1-5cm in diameter, KPS ≥ 70%, and absence of clinical decline which would have prevented enrollment on the PVSRIPO trial. Results: Fifteen pts were treated in the dose escalation phase, dose levels 1-5 (1 each at dose levels 1 and 3, 7 at level 2, 2 at level 4, and 4 at level 5), while 124 pts were identified as historical controls. Patient characteristics were similar for age, gender, KPS, prior number of progressions, steroid dosage at enrollment, and prior bevacizumab failure; however, 80% of PVSRIPO pts versus 58.9% of control pts had a gross total resection at diagnosis. As of 1/15/16, a median OS of 12.6 months was observed for the PVSRIPO group versus 10.5 months for the historical controls, with 23.3% of PVSRIPO pts alive at 24 months versus 13.7% of historical controls. Conclusions: Infusion of PVSRIPO via CED seems to have a survival advantage when compared to historical control pts treated at the same institution, with a higher proportion of patients alive at 24 months. Reported pts were not treated at what was identified as the optimal dose of PVSRIPO (dose level -1). It is predicted that the pts treated at the optimal dose will have a greater increase in survival. Clinical trial

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

May 20, 2016

Volume

34

Issue

15_suppl

Start / End Page

2061 / 2061

Location

Chicago, IL

Publisher

American Society of Clinical Oncology (ASCO)

Conference Name

2016 ASCO Annual Meeting

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
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ICMJE
MLA
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Desjardins, A., Sampson, J. H., Peters, K. B., Vlahovic, G., Randazzo, D., Threatt, S., … Gromeier, M. (2016). Patient survival on the dose escalation phase of the Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG) clinical trial compared to historical controls. In Journal of Clinical Oncology (Vol. 34, pp. 2061–2061). Chicago, IL: American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2016.34.15_suppl.2061
Desjardins, Annick, John H. Sampson, Katherine B. Peters, Gordana Vlahovic, Dina Randazzo, Stevie Threatt, James Emmett Herndon, et al. “Patient survival on the dose escalation phase of the Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG) clinical trial compared to historical controls.” In Journal of Clinical Oncology, 34:2061–2061. American Society of Clinical Oncology (ASCO), 2016. https://doi.org/10.1200/jco.2016.34.15_suppl.2061.
Desjardins A, Sampson JH, Peters KB, Vlahovic G, Randazzo D, Threatt S, et al. Patient survival on the dose escalation phase of the Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG) clinical trial compared to historical controls. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2016. p. 2061–2061.
Desjardins, Annick, et al. “Patient survival on the dose escalation phase of the Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG) clinical trial compared to historical controls.Journal of Clinical Oncology, vol. 34, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2016, pp. 2061–2061. Manual, doi:10.1200/jco.2016.34.15_suppl.2061.
Desjardins A, Sampson JH, Peters KB, Vlahovic G, Randazzo D, Threatt S, Herndon JE, Boulton S, Lally-Goss D, McSherry F, Lipp ES, Friedman AH, Friedman HS, Bigner DD, Gromeier M. Patient survival on the dose escalation phase of the Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG) clinical trial compared to historical controls. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2016. p. 2061–2061.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

May 20, 2016

Volume

34

Issue

15_suppl

Start / End Page

2061 / 2061

Location

Chicago, IL

Publisher

American Society of Clinical Oncology (ASCO)

Conference Name

2016 ASCO Annual Meeting

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences