High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer

Study ID
STU 012013-041

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services

Kristi Louder

Principal Investigator
Raquibul Hannan

Official Title

A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Metastatic Clear Cell Renal Cell Cancer (mRCC)

Brief Overview

In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the
stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites
of bulky progressive disease, but also to provide antigen presentation and immune
stimulation which is expected to act synergistically when immediately followed by the
non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the
response rate and complete response for metastatic clear cell renal cell cancer patients.
Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment

Participant Eligibility

Inclusion Criteria:

1. Biopsy-proven metastatic clear cell RCC.

2. Radiographic evidence of metastatic disease. 2.1 Patients with any number of
metastatic site are allowed to enroll. However, only up to six sites will be selected
for SBRT treatment, at the discretion of the treating radiation oncologist.

3. Patient must have ≥1 lesion of size >1.5cm.

4. Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any
targeted agents are allowed 28 days before the start of HD IL-2

5. Age ≥ 18 years.

6. Performance status ECOG 0, 1.

7. Patient must be eligible for HD IL-2 treatment

8. Patient must be eligible for SABR to one or more extra cranial sites.

9. Adequate organ and marrow function as defined below:

- leukocytes ≥ 3,000/mcL

- absolute neutrophil count ≥ 1,500/mcL

- platelets ≥ 50,000/mcl

- total bilirubin ≤ 2mg/dL

- AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal

10. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician

10.1 A female of child-bearing potential is any woman (regardless of sexual
orientation, having undergone a tubal ligation, or remaining celibate by choice) who
meets the following criteria:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months).

11. Ability to understand and the willingness to sign a written informed consent

12. Adequate Renal function with Cr ≤ 1.6 mg/dL.

13. Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc)
stress test

14. Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%).

Exclusion Criteria:

1. Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering
the study

2. History of HIV, Hepatitis B, Hepatitis C and HTLV serology

3. Subjects may not be receiving any other investigational or standard antineoplastic

4. Subjects with known brain metastases should be excluded from this clinical trial
because of their poor prognosis

5. Subjects with life expectancy < 6 months.

6. History of allergic reactions to recombinant IL-2

7. Uncontrolled recurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac

8. Psychiatric illness/social situations that would limit compliance with study

9. Subjects must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants.

10. Systemic or topical steroid use or other immunosuppressive therapy within the past 28

11. Subjects required to take corticosteroids or other immunosuppressive therapy such as
those with organ allograft