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Title:
Studying the Pathologic and Immunologic Response after Ablative Radiation in Stage I Non-Small Cell Lung Cancer (SPARC)
Protocol Number:
J1826
Phase:
Pilot
Physician:
Khinh Voong
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
a pilot study to compare pre- and post-SABR core biopsies of stage I NSCLC tumors to identify SABR-induced immune-mediated tumor recognition based on a significant and specific expansion of T-cell clones using a novel T-cell receptor (TCR) sequencing assay. This will be coupled with (1) novel genomic analysis of candidate tumor antigens that may be released from the pre-SABR tumor and (2) functional validation assays to screen post-treatment peripheral blood T-cells for reactivity to these released candidate tumor antigens. In addition, cell-based analysis will be used to identify changes in key T-cell infiltrates into the post-SABR tumor. The results of this pilot study may have the potential to translate into improved systemic outcomes for patients with NSCLC through future integrated trials of immune checkpoint blockade antibodies that specifically relieve the immunosuppression on the T-cell population found to be activated by SABR.
Eligibility:
Histologic or Cytologic Non-Small cell lung cancer, (Stage 1, T1a-T2a, N0, M0), less than 4cm nodule accessible tumor for biopsy, Tumor amenable to SABR treatment, Not receiving any other concurrent investigational agents, chemo or immunotherapy, No prior thoracic radiation in the region that is treated with SABR, No prior current use of oral steroids with 14 days before radiation
Treatment:
1) Eligibility confirmation, 6 Core Biopsies, 120mL blood, Dual Energy CT, Enrollment2) 4 Daily SABR treatments (48 Gy total OR 50 Gy over 5d days)3) Prior to 2nd SABR treatment 20 mL of study whole blood will be obtained4) Post SABR study peripheral blood collection and post-SABR study DE-CT will be conducted in the 0-24 hours preceding the scheduled post-SABR biopsy5) Post-SABR study biopsy will be conducted on the 5th to 7th day after completion of SABR6) Follow-up visits: 120cc of study blood to be obtained and stored on months 3, 6 and 12
Population:
Adult
Last Update
03/05/2019 05:03 AM