Supplementary Materials

Supplementary Material for:

Phase 1 trial of vocimagene amiretrorepvec and 5-fluorocytosine for recurrent high-grade glioma

Timothy F. Cloughesy, Joseph Landolfi, Daniel J. Hogan, Stephen Bloomfield, Bob Carter, Clark C. Chen, J. Bradley Elder, Steven N. Kalkanis, Santosh Kesari, Albert Lai, Ian Y. Lee, Linda M. Liau, Tom Mikkelsen, Phioanh Leia Nghiemphu, David Piccioni, Tobias Walbert, Alice Chu, Asha Das, Oscar R. Diago, Dawn Gammon, Harry E. Gruber, Michelle Hanna, Douglas J. Jolly, Noriyuki Kasahara, David McCarthy, Leah Mitchell, Derek Ostertag, Joan M. Robbins, Maria Rodriguez-Aguirre, Michael A. Vogelbaum*

*Corresponding author. Email: vogelbm{at}ccf.org

Published 1 June 2016, Sci. Transl. Med. 8, 341ra75 (2016)
DOI: 10.1126/scitranslmed.aad9784

This PDF file includes:

  • Materials and Methods
  • Fig. S1. Simplified schematic for the phase 1 trial (NCT01470794).
  • Fig. S2. Tumor-specific Toca 511 staining in re-resected tumors after multiple cycles of Toca FC.
  • Fig. S3. Evidence of potential pseudoprogression on resected tumor after Toca 511 and Toca FC treatment.
  • Fig. S4. Comparison of subjects with glioblastoma at first or second recurrence treated with Toca 511 and Toca FC to lomustine.
  • Fig. S5. Peripheral blood CD4+ T cell modulation after Toca 511 and Toca FC dosing.
  • Fig. S6. Tracking of Toca 511 DNA and RNA signal in whole blood and plasma over time.
  • Fig. S7. Molecular classification of tumor samples from study subjects based on mRNA expression.
  • Fig. S8. Intratumor versus intertumor heterogeneity in RNA expression profiles.
  • Fig. S9. No relationship between variation in mRNA expression and confounding technical factors.
  • Fig. S10. No correlation between neural subtype and prognosis in newly diagnosed glioblastoma.
  • Fig. S11. Identification of an mRNA profile (SRNS) associated with longer survival after Toca 511.
  • Fig. S12. No correlation between SRNS and prognosis in newly diagnosed glioblastoma.
  • Fig. S13. Study survival–related neural subtype samples likely derive from nonenhancing regions of tumors.
  • Fig. S14. Negative expression between SPOC1 expression and subject survival time with Toca 511 and Toca FC therapy.
  • Fig. S15. MGMT promoter methylation.
  • Table S1. Toca 511 and Toca FC: Baseline demographic and clinical characteristics.
  • Table S2. Additional baseline demographic and clinical characteristics.
  • Table S3. Dosing cohorts.
  • Table S4. Detection of Toca 511 in re-resected tumors.
  • Table S5. Best overall response in the efficacy evaluable population.
  • Table S6. Adverse events and serious adverse events related to Toca 511 and Toca FC.
  • Table S7. Related adverse events: Toca 511 and Toca FC compared to lomustine.
  • Table S8. Adverse events regardless of attribution: Toca 511 and Toca FC compared to lomustine.
  • Table S9. Summary of multivariate analysis for survival (TCGA neural signature).
  • Table S10. Summary of multivariate analysis for survival (SRNS signature).
  • References (45, 46)

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Other Supplementary Material for this manuscript includes the following:

  • Table S11 (Microsoft Excel format). RNA sequencing normalized results (reads per kilobase of transcript per million mapped reads values).
  • Table S12 (Microsoft Excel format). SRNS gene list.
  • Table S13 (Microsoft Excel format). Subject summary.