Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy

Mayo Clinic

Status: Completed

Conditions: Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05112627

NCI-2021-10794 (Registry Identifier)

ROR2051 (Other Identifier)

20-011522 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Observational (biospecimen collection)

Description:

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

Treatment:

Procedure: Biospecimen Collection