IL-2 + SBRT for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBrendan Curti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday before the Monday on which IL-2 starts.

Eligibility Criteria

This trial is for adults with clear cell renal cancer, who are in good physical condition (ECOG 0-1), not pregnant, and can have specific tumors treated with SBRT. They must consent to join a patient registry and meet certain blood test criteria. Excluded are those with active infections, brain metastases unsuitable for radiosurgery, significant heart or lung issues, or previous radiation where SBRT would be directed.

Inclusion Criteria

Patients must sign a study-specific consent form

Patients must agree to participate in the Prometheus IL-2 patient registry (PROCLAIM registry)

My tumor can be targeted with focused radiation due to its size and location.

+4 more

Exclusion Criteria

My brain cancer cannot be treated with radiosurgery alone.

You have signs of reduced blood flow to your heart during a stress test or EKG.

Your blood test results must be within the specified range outlined in the study guidelines.

+6 more

Participant Groups

The study tests high dose Interleukin-2 (IL-2) therapy combined with Stereotactic Body Radiation (SBRT). Patients will receive multiple IL-2 doses over several cycles. Those in the SBRT group get two radiation treatments before starting IL-2 to see if this combination improves outcomes compared to IL-2 alone.

2Treatment groups

Experimental Treatment

Active Control

Group I: High Dose IL-2 and SBRTExperimental Treatment2 Interventions

Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts (the following Monday). Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.

Group II: High Dose IL-2Active Control1 Intervention

Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to the IL-2 arm who have disease progression after the first two IL-2 cycles have the option to receive SBRT followed by 2 additional cycles of IL-2.