Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Renal Cancer

Who is this study for? Patients with metastatic renal cancer
What treatments are being studied? High Dose IL-2
Status: Active_not_recruiting
Location: See location...
Intervention Type: Radiation, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological confirmation of predominant conventional (clear cell) renal cancer

• Patients must be ≥ 18 years of age

• Tumors amenable to SBRT in lungs (central locations preferred), mediastinum, chest wall, bones with a soft tissue component (other than long bones), or liver, liver hilum and associated lymph nodes (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of protocol treatment. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy

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

• Patients must sign a study-specific consent form

Locations
United States
Oregon
Portland Providence Medical Center
Portland
Time Frame
Start Date: 2014-12
Completion Date: 2026-12
Participants
Target number of participants: 84
Treatments
Active_comparator: High Dose IL-2
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.
Experimental: High Dose IL-2 and SBRT
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.
Related Therapeutic Areas
Sponsors
Leads: Providence Health & Services
Collaborators: Prometheus Laboratories, Cytokine Working Group

This content was sourced from clinicaltrials.gov