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Clinical Trials: Immunotherapy

Cytokines Produced by Dendritic Cells Administered Intratumorally Correlate with Clinical Outcome in Patients with Diverse Cancers

Vivek Subbiah, Ravi Murthy, David S. Hong, Robert M. Prins, Chitra Hosing, Kyle Hendricks, Deepthi Kolli, Lori Noffsinger, Robert Brown, Mary McGuire, Siquing Fu, Sarina Piha-Paul, Aung Naing, Anthony P. Conley, Robert S. Benjamin, Indreshpal Kaur and Marnix L. Bosch
Vivek Subbiah
1Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • For correspondence: vsubbiah@mdanderson.org
Ravi Murthy
2Department of Interventional Radiology, Division of Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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David S. Hong
1Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Robert M. Prins
3Department of Neurosurgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
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Chitra Hosing
4Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Kyle Hendricks
5Cognate Bioservices, Memphis, Tennessee.
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Deepthi Kolli
5Cognate Bioservices, Memphis, Tennessee.
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Lori Noffsinger
5Cognate Bioservices, Memphis, Tennessee.
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Robert Brown
6Department of Pathology and Laboratory Medicine, UT Health, University of Texas Health Science Center, Houston, Texas.
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Mary McGuire
6Department of Pathology and Laboratory Medicine, UT Health, University of Texas Health Science Center, Houston, Texas.
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  • ORCID record for Mary McGuire
Siquing Fu
1Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Sarina Piha-Paul
1Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Aung Naing
1Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Anthony P. Conley
7Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Robert S. Benjamin
7Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Indreshpal Kaur
8Cell Therapy Labs, GMP Laboratory, Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Marnix L. Bosch
9Northwest Biotherapeutics, Inc., Bethesda, Maryland.
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DOI: 10.1158/1078-0432.CCR-17-2707 Published August 2018
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Abstract

Purpose: Dendritic cells (DC) initiate adaptive immune responses through the uptake and presentation of antigenic material. In preclinical studies, intratumorally injected activated DCs (aDCs; DCVax-Direct) were superior to immature DCs in rejecting tumors from mice.

Experimental Design: This single-arm, open-label phase I clinical trial evaluated the safety and efficacy of aDCs, administered intratumorally, in patients with solid tumors. Three dose levels (2 million, 6 million, and 15 million aDCs per injection) were tested using a standard 3 + 3 dose-escalation trial design. Feasibility, immunogenicity, changes to the tumor microenvironment after direct injection, and survival were evaluated. We also investigated cytokine production of aDCs prior to injection.

Results: In total, 39 of the 40 enrolled patients were evaluable. The injections of aDCs were well tolerated with no dose-limiting toxicities. Increased lymphocyte infiltration was observed in 54% of assessed patients. Stable disease (SD; best response) at week 8 was associated with increased overall survival. Increased secretion of interleukin (IL)-8 and IL12p40 by aDCs was significantly associated with survival (P = 0.023 and 0.024, respectively). Increased TNFα levels correlated positively with SD at week 8 (P < 0.01).

Conclusions: Intratumoral aDC injections were feasible and safe. Increased production of specific cytokines was correlated with SD and prolonged survival, demonstrating a link between the functional profile of aDCs prior to injection and patient outcomes. Clin Cancer Res; 24(16); 3845–56. ©2018 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received October 10, 2017.
  • Revision received February 5, 2018.
  • Accepted May 7, 2018.
  • Published first July 17, 2018.
  • ©2018 American Association for Cancer Research.
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Clinical Cancer Research: 24 (16)
August 2018
Volume 24, Issue 16
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Cytokines Produced by Dendritic Cells Administered Intratumorally Correlate with Clinical Outcome in Patients with Diverse Cancers
Vivek Subbiah, Ravi Murthy, David S. Hong, Robert M. Prins, Chitra Hosing, Kyle Hendricks, Deepthi Kolli, Lori Noffsinger, Robert Brown, Mary McGuire, Siquing Fu, Sarina Piha-Paul, Aung Naing, Anthony P. Conley, Robert S. Benjamin, Indreshpal Kaur and Marnix L. Bosch
Clin Cancer Res August 15 2018 (24) (16) 3845-3856; DOI: 10.1158/1078-0432.CCR-17-2707

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Cytokines Produced by Dendritic Cells Administered Intratumorally Correlate with Clinical Outcome in Patients with Diverse Cancers
Vivek Subbiah, Ravi Murthy, David S. Hong, Robert M. Prins, Chitra Hosing, Kyle Hendricks, Deepthi Kolli, Lori Noffsinger, Robert Brown, Mary McGuire, Siquing Fu, Sarina Piha-Paul, Aung Naing, Anthony P. Conley, Robert S. Benjamin, Indreshpal Kaur and Marnix L. Bosch
Clin Cancer Res August 15 2018 (24) (16) 3845-3856; DOI: 10.1158/1078-0432.CCR-17-2707
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