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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01777802
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prostate Cancer; Breast Cancer; Lung Cancer; Melanoma	Radiation: SBRT; Radiation: IMRT; Radiation: Brachytherapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 130 participants
• 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
• Actual Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers. [Before and after SBRT, IMRT, or brachytherapy]

   Changes in baseline circulating tumor reactive immune markers after radiotherapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Sean S Park, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Sean S. Park, Assistant Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01777802
• Other Study ID Numbers: 12-008383
• First Posted: Jan 29, 2013
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Breast Neoplasms; Melanoma

Study Results

No Results Posted as of Jan 13, 2022