Status:
COMPLETED
High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Prometheus Laboratories
Conditions:
Metastatic Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 disea...
Eligibility Criteria
Inclusion
- Biopsy-proven metastatic clear cell RCC.
- 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.
- Patient must have ≥1 lesion of size \>1.5cm.
- Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2
- Age ≥ 18 years.
- Performance status ECOG 0, 1.
- Patient must be eligible for HD IL-2 treatment
- Patient must be eligible for SABR to one or more extra cranial sites.
- 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
- 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 immediately.
- 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).
- Ability to understand and the willingness to sign a written informed consent
- Adequate Renal function with Cr ≤ 1.6 mg/dL.
- Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test
- Adequate pulmonary function on PFT (FEV1 \>65%; DLCO\>60%).
Exclusion
- Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- History of HIV, Hepatitis B, Hepatitis C and HTLV serology
- Subjects may not be receiving any other investigational or standard antineoplastic agents.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis
- Subjects with life expectancy \< 6 months.
- History of allergic reactions to recombinant IL-2
- Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days
- Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
Key Trial Info
Start Date :
October 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01896271
Start Date
October 2 2013
End Date
April 20 2021
Last Update
August 23 2021
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390