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Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy (SBRT)

This study is currently recruiting participants.
Verified August 2017 by Sean S. Park, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777802
First Posted: January 29, 2013
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean S. Park, Mayo Clinic
  Purpose
Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.

Condition Intervention
Prostate Cancer Breast Cancer Lung Cancer Melanoma Radiation: SBRT Radiation: IMRT Radiation: Brachytherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy

Resource links provided by NLM:


Further study details as provided by Sean S. Park, Mayo Clinic:

Primary Outcome Measures:
  • Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers. [ Time Frame: Before and after SBRT, IMRT, or brachytherapy ]
    Changes in baseline circulating tumor reactive immune markers after radiotherapy.


Biospecimen Retention:   Samples Without DNA
Whole Blood

Estimated Enrollment: 130
Study Start Date: January 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prostate Cancer
Patients with prostate cancer will be treated with SBRT, IMRT or brachytherapy
Radiation: SBRT Radiation: IMRT Radiation: Brachytherapy
Breast Cancer
Patients with breast cancer will be treated with SBRT, IMRT or brachytherapy
Radiation: SBRT Radiation: IMRT Radiation: Brachytherapy
Lung Cancer
Patients with lung cancer will be treated with SBRT, IMRT or brachytherapy
Radiation: SBRT Radiation: IMRT Radiation: Brachytherapy
Melanoma Cancer
Patients with melanoma cancer will be treated with SBRT, IMRT or brachytherapy
Radiation: SBRT Radiation: IMRT Radiation: Brachytherapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Oligometastatic prostate, lung, breast and melanoma patients
Criteria

Inclusion Criteria:

  • Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer

Exclusion Criteria:

-Life expectancy of less than 3 months

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777802


Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Sean S Park, M.D., Ph.D.         
Sub-Investigator: Eugene D Kwon, M.D.         
Sub-Investigator: Haidong Dong, M.D., Ph.D.         
Sub-Investigator: Kenneth R Olivier, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sean S Park, MD, PhD Mayo Clinic
  More Information

Responsible Party: Sean S. Park, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01777802     History of Changes
Other Study ID Numbers: 12-008383
First Submitted: January 24, 2013
First Posted: January 29, 2013
Last Update Posted: August 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Breast Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas