Trial Outcomes & Findings for Interleukin-2 in Metastatic Kidney Cancer (NCT NCT01702909)

Last Updated: 2018-02-08

Results Overview

Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Measured until Disease Progression or death from any cause up to 2 year

Results posted on

2018-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Interleukin-2 Interleukin 2 (IL-2) is naturally produced by the body to help fight infection and prevent autoimmune diseases. In cancer treatment, IL-2 is designed to target adaptive immune cells, such as T-cells and B-cells, to respond to tumors. IL-2 may help the body produce antigen-fighting T-cells and stimulate B-cells to produce more antibodies.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interleukin-2 in Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Number of Participants n=7 Participants Treated with Interleukin-2
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured until Disease Progression or death from any cause up to 2 year

Population: No data was collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured from first response until Disease Progression or death from any cause up to 2 years

Population: There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.

Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors \[RECIST\] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured from date of first dose until date of death

Population: There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.

from time of study entry until death

Outcome measures

Outcome data not reported

Adverse Events

Serious events: 0 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adverse Events n=7 participants at risk Patients receiving Interleukin-2
Gastrointestinal disorders Nausea/emesis	100.0% 7/7 • Through study completion, approximately 2 years
Metabolism and nutrition disorders Decreased appetite	85.7% 6/7 • Through study completion, approximately 2 years
General disorders Rigors	85.7% 6/7 • Through study completion, approximately 2 years
General disorders Catarrhal/sinus symptoms	71.4% 5/7 • Through study completion, approximately 2 years
Gastrointestinal disorders Constipation	57.1% 4/7 • Through study completion, approximately 2 years
Musculoskeletal and connective tissue disorders Arthalgia/myalgia	57.1% 4/7 • Through study completion, approximately 2 years
General disorders Fever	57.1% 4/7 • Through study completion, approximately 2 years
General disorders Peripheral swelling	57.1% 4/7 • Through study completion, approximately 2 years
Skin and subcutaneous tissue disorders Skin rash	42.9% 3/7 • Through study completion, approximately 2 years
Nervous system disorders Headache	42.9% 3/7 • Through study completion, approximately 2 years
Investigations Elevated creatinine	28.6% 2/7 • Through study completion, approximately 2 years
General disorders Fatigue	28.6% 2/7 • Through study completion, approximately 2 years
Vascular disorders Hypotension	14.3% 1/7 • Through study completion, approximately 2 years

Additional Information

Jessica L. Coats

Western Regional Medical Center

Phone: 623-207-3899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place