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

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ClinicalTrials.gov Identifier: NCT01896271
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : August 23, 2021
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE July 5, 2013
First Posted Date  ICMJE July 11, 2013
Results First Submitted Date  ICMJE July 28, 2021
Results First Posted Date  ICMJE August 23, 2021
Last Update Posted Date August 23, 2021
Actual Study Start Date  ICMJE October 2, 2013
Actual Primary Completion Date August 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2021)
Response Rate [ Time Frame: 6 months ]
Treatment response will be measured using the immune related Response Evaluation Criteria in Solid Tumors (RECIST) criteria (iRECIST) which are a minor modification of RECIST 1.1 for immunotherapy
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
Response rate [ Time Frame: 6 months ]
To evaluate the response rate (RR) in patients with mRCC after treatment with HD IL-2 immediately following SABR to multiple metastatic sites. RR has been highly correlated (p<0.0001) to overall survival. RECIST 1.1 criteria will be used to measure RR and it will consist of complete response (CR) and partial response (PR)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2021)
  • Overall Survival [ Time Frame: 4 years ]
    Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
  • Progression Free Survival [ Time Frame: 4 years ]
    Progression Free Survival (PFS), which is defined according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST) as the time between date of registration and the first date of documented disease progression or date of death due to any cause.
  • Time to Progression [ Time Frame: 4 years ]
    Time to Progression (TTP), which is defined as time between date of registration and date of documented progression
  • Local Control Rate [ Time Frame: 4 years ]
    Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size.
  • Median Response Duration [ Time Frame: 4 years ]
    Median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression
  • Tumor-specific Immune Response [ Time Frame: 4 years ]
    Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.
  • Number of Participants With Adverse Events [ Time Frame: 4 years ]
    Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
  • Health-related Quality of Life (HRQoL). [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
  • Overall survival [ Time Frame: 4 years ]
    To evaluate the overall survival (OS), which is defined as the time between date of registration and the date of death due to any cause. In analyzing the OS, it is important to take into account the MSKCC prognostic criteria defined by Motzer et. al. mRCC patients and compare the outcome in the appropriate risk categories
  • Progression free survival [ Time Frame: 4 years ]
    To evaluate progression free survival (PFS), which is defined as the time between date of registration and the first date of documented disease progression or date of death due to any cause.
  • Time to progression [ Time Frame: 4 years ]
    To evaluate time to progression (TTP), which is defined as time between date of registration and date of documented progression
  • Median response duration [ Time Frame: 4 years ]
    To evaluate median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression
  • Local control rate [ Time Frame: 4 years ]
    To evaluate the local control rate of irradiated lesions
  • Tumor-specific immune response [ Time Frame: 4 years ]
    To measure treatment-related tumor-specific immune response
  • Toxicity [ Time Frame: 4 years ]
    To evaluate the tolerability and toxicity of this regiment as measured according to CTCAE v4.0.
  • Health-related quality of life (HRQoL). [ Time Frame: 4 years ]
    To measure the improvement in health-related quality of life (HRQoL)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
Official Title  ICMJE 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 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 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Clear Cell Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: IL-2
    HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion
  • Radiation: Stereotactic Ablative Body Radiation Therapy
    SABR dose varying from 8Gy-20Gy in 1-3 fractions
    Other Name: SABR, SBRT
Study Arms  ICMJE Experimental: treatment
HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.
Interventions:
  • Drug: IL-2
  • Radiation: Stereotactic Ablative Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2013)
26
Actual Study Completion Date  ICMJE April 20, 2021
Actual Primary Completion Date August 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 immediately.

    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 agents.
  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 arrhythmia,.
  8. Psychiatric illness/social situations that would limit compliance with study requirements.
  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 days
  11. Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896271
Other Study ID Numbers  ICMJE STU 012013-041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raquibul Hannan, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Prometheus Laboratories
Investigators  ICMJE
Principal Investigator: Raquibul Hannan, MD, PhD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP