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David Peereboom - One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind placebo controlled phase ii trial of dendritic cell vaccine ict 107 in newly diagnosed patients with glioblastoma
    Clinical Cancer Research, 2019
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, Terri S Armstrong, David Peereboom
    Abstract:

    Purpose: To evaluate the results of the randomized, double-blind, placebo-controlled phase II clinical trial of ICT-107 in patients with newly diagnosed glioblastoma. Patients and Methods: We conducted a double-blinded randomized phase II trial of ICT-107 in newly diagnosed patients with glioblastoma (GBM) and tested efficacy, safety, quality of life (QoL), and immune response. HLA-A1+ and/or -A2+–resected patients with residual tumor ≤1 cm3 received radiotherapy and concurrent temozolomide. Following completion of radiotherapy, 124 patients, randomized 2:1, received ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell–associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC). Patients received induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide. Maintenance vaccinations occurred at 1, 3, and 6 months and every 6 months thereafter. Results: ICT-107 was well tolerated, with no difference in adverse events between the treatment and control groups. The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant. Progression-free survival (PFS) in the ITT population was significantly increased in the ICT-107 cohort by 2.2 months (P = 0.011). The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher immune response (via Elispot). HLA-A2 patients achieved a meaningful therapeutic benefit with ICT-107, in both the MGMT methylated and unmethylated prespecified subgroups, whereas only HLA-A1 methylated patients had an OS benefit. Conclusions: PFS was significantly improved in ICT-107–treated patients with maintenance of QoL. Patients in the HLA-A2 subgroup showed increased ICT-107 activity clinically and immunologically.

  • at 60a randomized double blind placebo controlled phase 2 trial of dendritic cell dc vaccine ict 107 following standard treatment in newly diagnosed patients with gbm
    Neuro-oncology, 2014
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, David Peereboom, James M Markert
    Abstract:

    BACKGROUND: This double-blinded randomized phase 2 trial of ICT-107 in newly-diagnosed glioblastoma (GBM) patients rigorously tested efficacy, safety, QoL, and immune response. METHODS: HLA-A1+ and/or -A2+ resected patients with residual tumor <1 cm3 received 6wks of concurrent temozolomide (TMZ) and radiation. 124 patients, randomized 2:1, received ICT-107 (autologous DCs pulsed with 6 synthetic peptide CTL epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL-13Rα2) or matching control (unpulsed DC). Patients then received induction ICT-107 or control QWx4 followed by maintenance TMZ, 5 days/mo for 12mos. Maintenance vaccinations occurred at 1, 3, and 6mos after induction, and every 6mos thereafter until progression. RESULTS: ICT-107 was generally safe and well tolerated, with no AE imbalance between treated and control. At the 67-event trial completion, median OS had not been reached. Follow-up continues: at 79 events, median OS favored ICT-107 by 1.6mos in the ITT and 1.9mos in the PP (117 patients completing induction) groups, although not statistically significant (p = 0.64 two-sided, HR = 0.89, and p = 0.48, HR = 0.84, respectively). Median PFS was significantly improved in the ICT-107 ITT and PP groups by 2.2mos and 2.4mos (p = 0.01, HR = 0.57, p = 0.006, HR = 0.54, respectively). Treatment extended PFS with sustained QoL assessed by FACT-BR, KPS, and steroid usage. The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher vaccine response (via Elispot) than HLA-A1 patients. PP HLA-A2 patients in both the MGMT methylated and unmethylated pre-specified subgroups saw a clinically meaningful ICT-107 effect, although HLA-A1 patients received no benefit from vaccine. CONCLUSIONS: PFS was significantly improved in ICT-107 treated patients with maintenance of QoL. Patients in the HLA-A2 MGMT subgroups show stronger ICT-107 activity clinically and immunologically, and these groups will be studied in a future phase 3 trial.

Patrick Y Wen - One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind placebo controlled phase ii trial of dendritic cell vaccine ict 107 in newly diagnosed patients with glioblastoma
    Clinical Cancer Research, 2019
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, Terri S Armstrong, David Peereboom
    Abstract:

    Purpose: To evaluate the results of the randomized, double-blind, placebo-controlled phase II clinical trial of ICT-107 in patients with newly diagnosed glioblastoma. Patients and Methods: We conducted a double-blinded randomized phase II trial of ICT-107 in newly diagnosed patients with glioblastoma (GBM) and tested efficacy, safety, quality of life (QoL), and immune response. HLA-A1+ and/or -A2+–resected patients with residual tumor ≤1 cm3 received radiotherapy and concurrent temozolomide. Following completion of radiotherapy, 124 patients, randomized 2:1, received ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell–associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC). Patients received induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide. Maintenance vaccinations occurred at 1, 3, and 6 months and every 6 months thereafter. Results: ICT-107 was well tolerated, with no difference in adverse events between the treatment and control groups. The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant. Progression-free survival (PFS) in the ITT population was significantly increased in the ICT-107 cohort by 2.2 months (P = 0.011). The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher immune response (via Elispot). HLA-A2 patients achieved a meaningful therapeutic benefit with ICT-107, in both the MGMT methylated and unmethylated prespecified subgroups, whereas only HLA-A1 methylated patients had an OS benefit. Conclusions: PFS was significantly improved in ICT-107–treated patients with maintenance of QoL. Patients in the HLA-A2 subgroup showed increased ICT-107 activity clinically and immunologically.

  • at 60a randomized double blind placebo controlled phase 2 trial of dendritic cell dc vaccine ict 107 following standard treatment in newly diagnosed patients with gbm
    Neuro-oncology, 2014
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, David Peereboom, James M Markert
    Abstract:

    BACKGROUND: This double-blinded randomized phase 2 trial of ICT-107 in newly-diagnosed glioblastoma (GBM) patients rigorously tested efficacy, safety, QoL, and immune response. METHODS: HLA-A1+ and/or -A2+ resected patients with residual tumor <1 cm3 received 6wks of concurrent temozolomide (TMZ) and radiation. 124 patients, randomized 2:1, received ICT-107 (autologous DCs pulsed with 6 synthetic peptide CTL epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL-13Rα2) or matching control (unpulsed DC). Patients then received induction ICT-107 or control QWx4 followed by maintenance TMZ, 5 days/mo for 12mos. Maintenance vaccinations occurred at 1, 3, and 6mos after induction, and every 6mos thereafter until progression. RESULTS: ICT-107 was generally safe and well tolerated, with no AE imbalance between treated and control. At the 67-event trial completion, median OS had not been reached. Follow-up continues: at 79 events, median OS favored ICT-107 by 1.6mos in the ITT and 1.9mos in the PP (117 patients completing induction) groups, although not statistically significant (p = 0.64 two-sided, HR = 0.89, and p = 0.48, HR = 0.84, respectively). Median PFS was significantly improved in the ICT-107 ITT and PP groups by 2.2mos and 2.4mos (p = 0.01, HR = 0.57, p = 0.006, HR = 0.54, respectively). Treatment extended PFS with sustained QoL assessed by FACT-BR, KPS, and steroid usage. The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher vaccine response (via Elispot) than HLA-A1 patients. PP HLA-A2 patients in both the MGMT methylated and unmethylated pre-specified subgroups saw a clinically meaningful ICT-107 effect, although HLA-A1 patients received no benefit from vaccine. CONCLUSIONS: PFS was significantly improved in ICT-107 treated patients with maintenance of QoL. Patients in the HLA-A2 MGMT subgroups show stronger ICT-107 activity clinically and immunologically, and these groups will be studied in a future phase 3 trial.

Jayjiguang Zhu - One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind placebo controlled phase ii trial of dendritic cell vaccine ict 107 in newly diagnosed patients with glioblastoma
    Clinical Cancer Research, 2019
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, Terri S Armstrong, David Peereboom
    Abstract:

    Purpose: To evaluate the results of the randomized, double-blind, placebo-controlled phase II clinical trial of ICT-107 in patients with newly diagnosed glioblastoma. Patients and Methods: We conducted a double-blinded randomized phase II trial of ICT-107 in newly diagnosed patients with glioblastoma (GBM) and tested efficacy, safety, quality of life (QoL), and immune response. HLA-A1+ and/or -A2+–resected patients with residual tumor ≤1 cm3 received radiotherapy and concurrent temozolomide. Following completion of radiotherapy, 124 patients, randomized 2:1, received ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell–associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC). Patients received induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide. Maintenance vaccinations occurred at 1, 3, and 6 months and every 6 months thereafter. Results: ICT-107 was well tolerated, with no difference in adverse events between the treatment and control groups. The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant. Progression-free survival (PFS) in the ITT population was significantly increased in the ICT-107 cohort by 2.2 months (P = 0.011). The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher immune response (via Elispot). HLA-A2 patients achieved a meaningful therapeutic benefit with ICT-107, in both the MGMT methylated and unmethylated prespecified subgroups, whereas only HLA-A1 methylated patients had an OS benefit. Conclusions: PFS was significantly improved in ICT-107–treated patients with maintenance of QoL. Patients in the HLA-A2 subgroup showed increased ICT-107 activity clinically and immunologically.

  • at 60a randomized double blind placebo controlled phase 2 trial of dendritic cell dc vaccine ict 107 following standard treatment in newly diagnosed patients with gbm
    Neuro-oncology, 2014
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, David Peereboom, James M Markert
    Abstract:

    BACKGROUND: This double-blinded randomized phase 2 trial of ICT-107 in newly-diagnosed glioblastoma (GBM) patients rigorously tested efficacy, safety, QoL, and immune response. METHODS: HLA-A1+ and/or -A2+ resected patients with residual tumor <1 cm3 received 6wks of concurrent temozolomide (TMZ) and radiation. 124 patients, randomized 2:1, received ICT-107 (autologous DCs pulsed with 6 synthetic peptide CTL epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL-13Rα2) or matching control (unpulsed DC). Patients then received induction ICT-107 or control QWx4 followed by maintenance TMZ, 5 days/mo for 12mos. Maintenance vaccinations occurred at 1, 3, and 6mos after induction, and every 6mos thereafter until progression. RESULTS: ICT-107 was generally safe and well tolerated, with no AE imbalance between treated and control. At the 67-event trial completion, median OS had not been reached. Follow-up continues: at 79 events, median OS favored ICT-107 by 1.6mos in the ITT and 1.9mos in the PP (117 patients completing induction) groups, although not statistically significant (p = 0.64 two-sided, HR = 0.89, and p = 0.48, HR = 0.84, respectively). Median PFS was significantly improved in the ICT-107 ITT and PP groups by 2.2mos and 2.4mos (p = 0.01, HR = 0.57, p = 0.006, HR = 0.54, respectively). Treatment extended PFS with sustained QoL assessed by FACT-BR, KPS, and steroid usage. The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher vaccine response (via Elispot) than HLA-A1 patients. PP HLA-A2 patients in both the MGMT methylated and unmethylated pre-specified subgroups saw a clinically meaningful ICT-107 effect, although HLA-A1 patients received no benefit from vaccine. CONCLUSIONS: PFS was significantly improved in ICT-107 treated patients with maintenance of QoL. Patients in the HLA-A2 MGMT subgroups show stronger ICT-107 activity clinically and immunologically, and these groups will be studied in a future phase 3 trial.

William T Curry - One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind placebo controlled phase ii trial of dendritic cell vaccine ict 107 in newly diagnosed patients with glioblastoma
    Clinical Cancer Research, 2019
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, Terri S Armstrong, David Peereboom
    Abstract:

    Purpose: To evaluate the results of the randomized, double-blind, placebo-controlled phase II clinical trial of ICT-107 in patients with newly diagnosed glioblastoma. Patients and Methods: We conducted a double-blinded randomized phase II trial of ICT-107 in newly diagnosed patients with glioblastoma (GBM) and tested efficacy, safety, quality of life (QoL), and immune response. HLA-A1+ and/or -A2+–resected patients with residual tumor ≤1 cm3 received radiotherapy and concurrent temozolomide. Following completion of radiotherapy, 124 patients, randomized 2:1, received ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell–associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC). Patients received induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide. Maintenance vaccinations occurred at 1, 3, and 6 months and every 6 months thereafter. Results: ICT-107 was well tolerated, with no difference in adverse events between the treatment and control groups. The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant. Progression-free survival (PFS) in the ITT population was significantly increased in the ICT-107 cohort by 2.2 months (P = 0.011). The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher immune response (via Elispot). HLA-A2 patients achieved a meaningful therapeutic benefit with ICT-107, in both the MGMT methylated and unmethylated prespecified subgroups, whereas only HLA-A1 methylated patients had an OS benefit. Conclusions: PFS was significantly improved in ICT-107–treated patients with maintenance of QoL. Patients in the HLA-A2 subgroup showed increased ICT-107 activity clinically and immunologically.

  • at 60a randomized double blind placebo controlled phase 2 trial of dendritic cell dc vaccine ict 107 following standard treatment in newly diagnosed patients with gbm
    Neuro-oncology, 2014
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, David Peereboom, James M Markert
    Abstract:

    BACKGROUND: This double-blinded randomized phase 2 trial of ICT-107 in newly-diagnosed glioblastoma (GBM) patients rigorously tested efficacy, safety, QoL, and immune response. METHODS: HLA-A1+ and/or -A2+ resected patients with residual tumor <1 cm3 received 6wks of concurrent temozolomide (TMZ) and radiation. 124 patients, randomized 2:1, received ICT-107 (autologous DCs pulsed with 6 synthetic peptide CTL epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL-13Rα2) or matching control (unpulsed DC). Patients then received induction ICT-107 or control QWx4 followed by maintenance TMZ, 5 days/mo for 12mos. Maintenance vaccinations occurred at 1, 3, and 6mos after induction, and every 6mos thereafter until progression. RESULTS: ICT-107 was generally safe and well tolerated, with no AE imbalance between treated and control. At the 67-event trial completion, median OS had not been reached. Follow-up continues: at 79 events, median OS favored ICT-107 by 1.6mos in the ITT and 1.9mos in the PP (117 patients completing induction) groups, although not statistically significant (p = 0.64 two-sided, HR = 0.89, and p = 0.48, HR = 0.84, respectively). Median PFS was significantly improved in the ICT-107 ITT and PP groups by 2.2mos and 2.4mos (p = 0.01, HR = 0.57, p = 0.006, HR = 0.54, respectively). Treatment extended PFS with sustained QoL assessed by FACT-BR, KPS, and steroid usage. The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher vaccine response (via Elispot) than HLA-A1 patients. PP HLA-A2 patients in both the MGMT methylated and unmethylated pre-specified subgroups saw a clinically meaningful ICT-107 effect, although HLA-A1 patients received no benefit from vaccine. CONCLUSIONS: PFS was significantly improved in ICT-107 treated patients with maintenance of QoL. Patients in the HLA-A2 MGMT subgroups show stronger ICT-107 activity clinically and immunologically, and these groups will be studied in a future phase 3 trial.

Michael Glantz - One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind placebo controlled phase ii trial of dendritic cell vaccine ict 107 in newly diagnosed patients with glioblastoma
    Clinical Cancer Research, 2019
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, Terri S Armstrong, David Peereboom
    Abstract:

    Purpose: To evaluate the results of the randomized, double-blind, placebo-controlled phase II clinical trial of ICT-107 in patients with newly diagnosed glioblastoma. Patients and Methods: We conducted a double-blinded randomized phase II trial of ICT-107 in newly diagnosed patients with glioblastoma (GBM) and tested efficacy, safety, quality of life (QoL), and immune response. HLA-A1+ and/or -A2+–resected patients with residual tumor ≤1 cm3 received radiotherapy and concurrent temozolomide. Following completion of radiotherapy, 124 patients, randomized 2:1, received ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell–associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC). Patients received induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide. Maintenance vaccinations occurred at 1, 3, and 6 months and every 6 months thereafter. Results: ICT-107 was well tolerated, with no difference in adverse events between the treatment and control groups. The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant. Progression-free survival (PFS) in the ITT population was significantly increased in the ICT-107 cohort by 2.2 months (P = 0.011). The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher immune response (via Elispot). HLA-A2 patients achieved a meaningful therapeutic benefit with ICT-107, in both the MGMT methylated and unmethylated prespecified subgroups, whereas only HLA-A1 methylated patients had an OS benefit. Conclusions: PFS was significantly improved in ICT-107–treated patients with maintenance of QoL. Patients in the HLA-A2 subgroup showed increased ICT-107 activity clinically and immunologically.

  • at 60a randomized double blind placebo controlled phase 2 trial of dendritic cell dc vaccine ict 107 following standard treatment in newly diagnosed patients with gbm
    Neuro-oncology, 2014
    Co-Authors: Patrick Y Wen, David A Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William T Curry, Jayjiguang Zhu, Michael Glantz, David Peereboom, James M Markert
    Abstract:

    BACKGROUND: This double-blinded randomized phase 2 trial of ICT-107 in newly-diagnosed glioblastoma (GBM) patients rigorously tested efficacy, safety, QoL, and immune response. METHODS: HLA-A1+ and/or -A2+ resected patients with residual tumor <1 cm3 received 6wks of concurrent temozolomide (TMZ) and radiation. 124 patients, randomized 2:1, received ICT-107 (autologous DCs pulsed with 6 synthetic peptide CTL epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL-13Rα2) or matching control (unpulsed DC). Patients then received induction ICT-107 or control QWx4 followed by maintenance TMZ, 5 days/mo for 12mos. Maintenance vaccinations occurred at 1, 3, and 6mos after induction, and every 6mos thereafter until progression. RESULTS: ICT-107 was generally safe and well tolerated, with no AE imbalance between treated and control. At the 67-event trial completion, median OS had not been reached. Follow-up continues: at 79 events, median OS favored ICT-107 by 1.6mos in the ITT and 1.9mos in the PP (117 patients completing induction) groups, although not statistically significant (p = 0.64 two-sided, HR = 0.89, and p = 0.48, HR = 0.84, respectively). Median PFS was significantly improved in the ICT-107 ITT and PP groups by 2.2mos and 2.4mos (p = 0.01, HR = 0.57, p = 0.006, HR = 0.54, respectively). Treatment extended PFS with sustained QoL assessed by FACT-BR, KPS, and steroid usage. The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher vaccine response (via Elispot) than HLA-A1 patients. PP HLA-A2 patients in both the MGMT methylated and unmethylated pre-specified subgroups saw a clinically meaningful ICT-107 effect, although HLA-A1 patients received no benefit from vaccine. CONCLUSIONS: PFS was significantly improved in ICT-107 treated patients with maintenance of QoL. Patients in the HLA-A2 MGMT subgroups show stronger ICT-107 activity clinically and immunologically, and these groups will be studied in a future phase 3 trial.