21st Century Oncology Translational Research Consortium TRC

Scottsdale, AZ, United States

21st Century Oncology Translational Research Consortium TRC

Scottsdale, AZ, United States
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Allison R.R.,21st Century Oncology Carolina Radiation Medicine | Ambrad A.A.,Ironwood Cancer and Research Centers | Arshoun Y.,Allegheny General Hospital | Carmel R.J.,John Muir Health Medical Center | And 16 more authors.
Cancer | Year: 2014

BACKGROUND The objective of this trial was to determine how a mucoadhesive hydrogel (MuGard), a marketed medical device, would fare when tested with the strictness of a conventional multi-institutional, double-blind, randomized, placebo-controlled study format. METHODS A total of 120 subjects planned to receive chemoradiation therapy (CRT) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse (SC) during CRT. Subjects completed the validated Oral Mucositis Daily Questionnaire. Weight, opiate use, and World Health Organization (WHO) oral mucositis (OM) scores were recorded. Subjects who dosed at least once daily during the first 2.5 weeks of CRT were included in the efficacy analysis. RESULTS Of 120 subjects enrolled, 78 (SC, N = 41; MuGard, N = 37) were eligible for efficacy analysis. Both cohorts were similar in demographics, baseline characteristics, primary tumor type, and planned CRT regimen. MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness (P = .034) and WHO scores on the last day of radiation therapy (P = .038). MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration, and OM scores (WHO criteria) at CRT week 4. Rinse compliance was identical between cohorts. No significant adverse events were reported, and the adverse event incidence was similar between cohorts. CONCLUSIONS Testing MuGard, a rinse marketed as a device, in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms, delaying OM progression, and its safety and tolerability. Cancer 2014;120:1433-1440. © 2014 Access Pharmaceuticals, Inc. Cancer published by Wiley Periodicals. Inc. on behalf of American Cancer Society. In a randomized, double-blind, placebo-controlled trial, the mucoadhesive hydrogel MuGard proved to be superior to saline-bicarbonate rinse in mitigating oral mucositis (OM) symptoms and delaying OM progression. MuGard was safe and well-tolerated, and favorably affected the rate and incidence of ulcerative lesions, consistent with the patient-reported outcomes. © 2014 American Cancer Society. Access Pharmaceuticals, Inc. Cancer published by Wiley Periodicals. Inc. on behalf of American Cancer Society.


Finkelstein S.E.,21st Century Oncology Translational Research Consortium TRC | Salenius S.,21st Century Oncology Translational Research Consortium | Mantz C.A.,21st Century Oncology Translational Research Consortium | Shore N.D.,Urologic | And 7 more authors.
Clinical Genitourinary Cancer | Year: 2015

Radiotherapy has conventionally been viewed as immunosuppressive, which has precluded its use in combination with immunotherapy for prostate and other cancers. However, the relationship between ionizing radiation and immune reactivity is now known to be more complex than was previously thought, and data on the use of radiotherapy and immunotherapy are accumulating. Herein, we review this topic in the light of recently available data in the prostate cancer setting. Recent research has shown no significant lymphopenia in patients undergoing radiotherapy for high-risk adenocarcinoma of the prostate. In addition, emerging evidence suggests that radiotherapy can have immunostimulatory effects, and that tumor cell death, coupled with related changes in antigen availability and inflammatory signals, can affect lymphocyte and dendritic cell activation. Initial studies have focused on combinations of tumor irradiation and immunotherapy, such as the autologous cellular immunotherapy sipuleucel-T and the monoclonal antibody ipilimumab, in metastatic castration-resistant prostate cancer. These combinations appear to have clinical promise, and further investigation of the potentially synergistic combination of radiotherapy and immunotherapy is continuing in clinical trials. © 2015 The Authors. All rights reserved.


Finkelstein S.E.,21st Century Oncology Translational Research Consortium TRC | Finkelstein S.E.,H. Lee Moffitt Cancer Center and Research Institute | Rodriguez F.,Florida Cancer Specialists | Dunn M.,H. Lee Moffitt Cancer Center and Research Institute | And 15 more authors.
Immunotherapy | Year: 2012

Local radiotherapy plus intratumoral syngeneic dendritic cell injection can mediate apoptosis/cell death and immunological tumor eradication in murine models. A novel method of coordinated intraprostatic, autologous dendritic cell injection together with radiation therapy was prospectively evaluated in five HLA-A2 + subjects with high-risk, localized prostate cancer, using androgen suppression, 45 Gy external beam radiation therapy in 25 fractions over 5 weeks, dendritic cell injections after fractions 5, 15 and 25 and then interstitial radioactive seed placement. Serial prostate biopsies before and during treatment showed increased apoptotic cells and parenchymal distribution of CD8 + cells. CD8 + T-cell responses to test peptides were assessed using an enzyme-linked immunosorbent spot IFN-γ production assay, demonstrating some prostate cancer-specific protein-derived peptides associated with increased titer. In conclusion, the technique was feasible and well-tolerated and specific immune responses were observable. Future trials could further test the utility of this approach and improve on temporal coordination of intratumoral dendritic cell introduction with particular timelines of therapy-induced apoptosis. © 2012 SE Finkelstein.


Metelmann H.-R.,University of Greifswald | Nedrelow D.S.,University of Minnesota | Seebauer C.,University of Greifswald | Schuster M.,University of Greifswald | And 7 more authors.
Clinical Plasma Medicine | Year: 2015

This study is a retrospective review of representing clinical follow-up of 12 patients afflicted with advanced squamous cell carcinoma of the head and neck. Herein, we have used novel physical cold atmospheric pressure plasma (CAP) to decontaminate infected cancer ulcerations and evaluated anti-cancer effects. With use of CAP in this cohort, the data suggests: (1) decreased request for pain medication and (2) reduction of typical fetid odor related to (3) reduction of microbial load. In some cases there is (4) superficial partial remission of tumor and even (5) wound healing of infected ulcerations has been observed following CAP exposure. As a result, CAP treatment appears of benefit for select head and neck cancer patients and future work to optimize CAP in the therapeutic armamentarium advances. © 2015 Elsevier GmbH.


Indelicato D.J.,Proton Therapy | Finkelstein S.E.,21st Century Oncology Translational Research Consortium TRC
Immunotherapy | Year: 2012

Soft tissue sarcomas represent a rare but diverse family of tumors affecting patients of all ages. Conventional chemotherapy rarely eradicates metastatic disease and newer targeted agents are successful in only very specific histologic subgroups. Therefore, scientists and clinicians are investigating immunotherapy techniques, primarily involving cellular immunity focused on the T-cell response to tumor antigens. In both animal models and human sarcoma trials, dendritic cells have been shown to induce an effective antitumor immune response. Radiotherapy, particularly when delivered in a hypofractionated manner prior to sarcoma excision, may potentiate the function of the dendritic cells through the induction of apoptosis. The synergistic effect may carry over to other cancer types and warrants further multidisciplinary investigation. © 2012 Future Medicine Ltd.


PubMed | 21st Century Oncology Translational Research Consortium TRC
Type: Journal Article | Journal: Immunotherapy | Year: 2012

Local radiotherapy plus intratumoral syngeneic dendritic cell injection can mediate apoptosis/cell death and immunological tumor eradication in murine models. A novel method of coordinated intraprostatic, autologous dendritic cell injection together with radiation therapy was prospectively evaluated in five HLA-A2(+) subjects with high-risk, localized prostate cancer, using androgen suppression, 45 Gy external beam radiation therapy in 25 fractions over 5 weeks, dendritic cell injections after fractions 5, 15 and 25 and then interstitial radioactive seed placement. Serial prostate biopsies before and during treatment showed increased apoptotic cells and parenchymal distribution of CD8(+) cells. CD8(+) T-cell responses to test peptides were assessed using an enzyme-linked immunosorbent spot IFN- production assay, demonstrating some prostate cancer-specific protein-derived peptides associated with increased titer. In conclusion, the technique was feasible and well-tolerated and specific immune responses were observable. Future trials could further test the utility of this approach and improve on temporal coordination of intratumoral dendritic cell introduction with particular timelines of therapy-induced apoptosis.

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