SAbR Induced Innate Immunity in Urothelial Carcinoma, Melanoma, and Cervical Carcinoma

NCT02986867 | Completed DMC

• 1 other identifier: STU 092016-055
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an exploratory prospective, single center study with correlative endpoints. The study will investigate the association of tumor cGAS STING signaling with SAbR. Tumor core biopsies will be processed and analyzed as described above. Medical records electronic medical records will be used to collect demographic and medical information and imaging studies.

Conditions

Urothelial Carcinoma; Melanoma; Cervical Carcinoma in Situ

Outcome Measures

Primary Outcomes (4)

• Comparison of immune checkpoint treated tumors

  Compare cGAMP levels, interferon response gene expression and phospho-STING in tumors of immune checkpoint treated patients.

  36 months

• SAbR effects on cGAMP in tumors

  Number of participants with SAbRrelated tumor changes indicated by cGAMP in comparison to Baseline.

  36 months

• SAbR effects on interferon response in tumors

  Number of participants with SAbRrelated tumor changes indicated by interferon response mRNAs in comparison to Baseline.

  36 months

• SAbR effects on phosphor-STING in tumors

  Number of participants with SAbRrelated tumor changes indicated by phospho-STING in comparison to Baseline.

  36 months

Study Arms (1)

SAbR

EXPERIMENTAL

SAbR treatment of lesions

Radiation: SAbR Treatment of Lesions

Interventions

SAbR Treatment of Lesions RADIATION

SAbR will be administered as per the guidelines of UTSW with a single 24-27Gy or three 10-14 Gy/fraction fractions totaling 33-48Gy. Lesions receiving SAbR will be called "radiated" lesions.

SAbR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of advanced/metastatic urothelial carcinoma, melanoma, or cervical carcinoma.
• Planned treated with SAbR.
• Age greater than or equal to 18 years.
• Lesion to receive SAbR safely accessible for core biopsy-mass \>1.5cm diameter and located in node, liver, or soft tissues.
• Hgb \>10g/dL before or after transfusion.
• Platelets \>50,000/L
• INR \<1.5
• If contrast enhanced CT needed to locate the lesion for core biopsy, then derived creatinine clearance \>30cc/min
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Prior radiation therapy to target lesion.
• Target lesion not safely accessible for core biopsies.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75063, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Melanoma; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Precancerous Conditions; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 8, 2016
• Study Start: June 13, 2017
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)