Clinical trial NCT05112627: Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy
Official title: Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histological or radiographic diagnosis of metastatic RCC

Brief summary: This early phase I trial evaluates blood samples to see if patients undergoing standard of care treatment with either stereotactic body radiation therapy or percutaneous ablation (using radio waves to create heat to destroy the tumor), have an increase in serum immune markers in kidney cancer. Information gained from this study may help doctors make treatment decisions for patients with kidney cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Compare pre- and post-treatment immune markers and peripheral blood mononuclear cell (PBMC) characteristics in metastatic renal cell carcinoma (RCC) patients overall.

II. Compare pre- and post-treatment immune markers and PBMC characteristics between patients being treated with stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and are also undergoing immunotherapy.

III. Compare pre- and post-treatment immune markers and PBMC characteristics in patients being treated with either SBRT or PCA and not undergoing immunotherapy.

IV. Assess the impact of post-treatment immune markers and PBMC characteristics on distant disease progression in metastatic RCC patients overall.

OUTLINE:

Patients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of primary RCC
* Histological or radiographic diagnosis of metastatic RCC
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* Feasible vascular access as determined by study staff
* Undergoing standard of care SBRT or PCA to RCC metastatic lesion(s)
* Provide written informed consent
* Willing to consent to research blood draws
* Willing to return to enrolling institution for follow-up

Exclusion Criteria:

* Prior local treatment of the index metastatic lesion
* Pregnant or nursing women
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry
* Patients receiving prophylactic steroids, defined as initiation of steroids within 1 week prior to local ablative therapy start, including the first day of local ablative therapy.

  * NOTE: Patients initiating steroids after the first day of local ablative therapy and within 14 days after local ablative therapy completion, will be allowed into the study and the use of steroids will be recorded.

Primary outcomes:
measure: Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Change in immune markers and PBMC characteristics in patients undergoing stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and receiving concurrent immunotherapy
timeFrame: Baseline up to 6 months
measure: Change in immune markers and PBMC characteristics in patients undergoing SBRT or PCA and not receiving concurrent immunotherapy
timeFrame: Baseline up to 6 months
measure: Levels of post-treatment immune markers and PBMC characteristics
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Bradley J. Stish, M.D.
role: PRINCIPAL_INVESTIGATOR
References: