Trial Outcomes & Findings for Interleukin-2 in Metastatic Melanoma (NCT NCT01702896)

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

8 participants

Primary outcome timeframe

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

Results posted on

2018-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Interleukin-2 All patients received Interleukin-2
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interleukin-2 in Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Number of Participants n=8 Participants Treated with Interleukin-2
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants

PRIMARY outcome

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

Population: Data not collected

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data not collected

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: From time of study entry until death, up to 10 years

Population: Data was not collected

Measured from date of entry on study until date of death

Outcome measures

Outcome data not reported

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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