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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01777802
Other study ID # 12-008383
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2013
Est. completion date January 2022

Study information

Verified date February 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date January 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer Exclusion Criteria: -Life expectancy of less than 3 months

Study Design


Intervention

Radiation:
SBRT

IMRT

Brachytherapy


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers. Changes in baseline circulating tumor reactive immune markers after radiotherapy. Before and after SBRT, IMRT, or brachytherapy
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