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

NCT02306954 | Active Not Recruiting Phase 2

• 1 other identifier: 14-256A
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

Kidney Cancer; High Dose IL-2; SBRT

Outcome Measures

Primary Outcomes (1)

• Response Rate

  The objective of this study is to compare the response rate among renal cell cancer (RCC) patients of high dose IL-2 to SBRT + IL-2 in patients with metastatic renal cancer

  5 years

Secondary Outcomes (1)

• Response Rate in Patients Who Receive SBRT following Progression on IL-2

  5 years

Study Arms (2)

High Dose IL-2

ACTIVE COMPARATOR

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.

Biological: High Dose IL-2

High Dose IL-2 and SBRT

EXPERIMENTAL

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.

Biological: High Dose IL-2; Radiation: SBRT

Interventions

High Dose IL-2 BIOLOGICAL

High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.

Also known as: Proleukin

High Dose IL-2; High Dose IL-2 and SBRT

SBRT RADIATION

Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before the Monday on which IL-2 starts.

High Dose IL-2 and SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No metastatic site amenable to SBRT
• Patients with brain metastases not candidates for radiosurgery alone
• Previous radiation to sites proposed for SBRT
• Patients with active systemic, pulmonary, or pericardial infection
• Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
• Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG
• Clinically significant underlying pulmonary disease as measured by pulmonary function tests
• Blood tests within protocol-specified range
• Need for chronic steroids

Sponsors & Collaborators

• Providence Health & Services: lead
• Prometheus Laboratories: collaborator
• Cytokine Working Group: collaborator

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Brendan Curti, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: December 3, 2014
• Study Start: December 1, 2014
• Primary Completion: September 15, 2020
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

US (1)