This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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.
See Contacts and Locations
Verified May 2017 by Sean S. Park, Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Sean S. Park, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01777802
First received: January 24, 2013
Last updated: May 23, 2017
Last verified: May 2017
  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, confromal 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 Breastcancer Lungcancer 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: June 2018
Estimated Primary Completion Date: January 2018 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 24, 2013
Last Updated: May 23, 2017

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

ClinicalTrials.gov processed this record on August 16, 2017