Trial Outcomes & Findings for High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer (NCT NCT01896271)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

6 months

Results posted on

2021-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Overall Study STARTED	30
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Overall Study Physician Decision	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=30 Participants 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Age, Continuous	51.5 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized White	25 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: There were 5 patients without measurable disease at baseline and 5 additional patients without 2nd scan to confirm progression. Hence, they were not analyzed.

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

Outcome measures

Outcome measures
Measure	Treatment n=20 Participants 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Response Rate	4 Participants

SECONDARY outcome

Timeframe: 4 years

Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Overall Survival	39 months Interval 16.0 to 53.0

SECONDARY outcome

Timeframe: 4 years

Population: There were 5 patients without measurable disease at baseline and 5 additional patients without 2nd scan to confirm progression. Hence, they were not analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment n=20 Participants 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Progression Free Survival	2.5 months Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 4 years

Population: This outcome measure was inadvertently added at the time of registration. This is same as progression free survival and measures and reports the exact same thing and is redundant. No separate data was collected from participants for this specific measure.

Time to Progression (TTP), which is defined as time between date of registration and date of documented progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=31 lesions 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Local Control Rate	30 lesions

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Treatment n=20 Participants 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Median Response Duration	26.7 months Interval 11.4 to 36.4

SECONDARY outcome

Timeframe: 4 years

Population: This data were never collected from the participants.

Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Number of Participants With Adverse Events	30 Participants

SECONDARY outcome

Timeframe: 4 years

Population: The data were never collected from the participants.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 22 serious events

Other events: 30 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=30 participants at risk 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Cardiac disorders Cardiac	10.0% 3/30 • 4 years
Gastrointestinal disorders Gastrointestinal	3.3% 1/30 • 4 years
Blood and lymphatic system disorders Hematology Coagulation	26.7% 8/30 • 4 years
Hepatobiliary disorders Hepatobiliary disorders	10.0% 3/30 • 4 years
Cardiac disorders Hypotension	6.7% 2/30 • 4 years
Infections and infestations Infection	10.0% 3/30 • 4 years
Nervous system disorders Neurologic	3.3% 1/30 • 4 years
General disorders Other	3.3% 1/30 • 4 years
Renal and urinary disorders Renal/electrolytes	36.7% 11/30 • 4 years
Respiratory, thoracic and mediastinal disorders Respiratory	10.0% 3/30 • 4 years

Other adverse events

Other adverse events
Measure	Treatment n=30 participants at risk 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. IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions
Cardiac disorders Cardiac	73.3% 22/30 • 4 years
General disorders Constitutional	90.0% 27/30 • 4 years
Gastrointestinal disorders Gastrointestinal	73.3% 22/30 • 4 years
Blood and lymphatic system disorders Hematology Coagulation	93.3% 28/30 • 4 years
Cardiac disorders Hypotension	60.0% 18/30 • 4 years
Infections and infestations Infection	16.7% 5/30 • 4 years
Nervous system disorders Neurologic	40.0% 12/30 • 4 years
General disorders Other	46.7% 14/30 • 4 years
Psychiatric disorders Psychiatric	20.0% 6/30 • 4 years
Renal and urinary disorders Renal/electrolytes	96.7% 29/30 • 4 years
Respiratory, thoracic and mediastinal disorders Respiratory	43.3% 13/30 • 4 years
Skin and subcutaneous tissue disorders Skin	70.0% 21/30 • 4 years
Hepatobiliary disorders Hepatobiliary disorders	63.3% 19/30 • 4 years

Additional Information

Dr. Raquibul Hannan

UT Southwestern Medical Center

Phone: 214-645-8525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place