Trial Outcomes & Findings for Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma (NCT NCT00414765)

NCT ID: NCT00414765

Last Updated: 2021-06-08

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

From Cycle 1, Day 1 to Cycle 2, Day 15

Results posted on

2021-06-08

Participant Flow

Participants took part at 4 investigative sites in the United States from 03-September-2008 to 28-March-2010.

A total of 26 participants were enrolled in the study. The study consisted of two cycles of aldesleukin, each cycle consisted of a 5-day period and a 9-day rest period between cycles.

Participant milestones

Participant milestones
Measure	mRCC Group Participants with metastatic renal cell carcinoma (mRCC) were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.	Metastatic Melanoma Group Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
Overall Study STARTED	7	19
Overall Study Completed Study	7	18
Overall Study Completed Cycle 1	7	19
Overall Study Completed Cycle 2	4	16
Overall Study COMPLETED	1	8
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Reasons for withdrawal
Measure	mRCC Group Participants with metastatic renal cell carcinoma (mRCC) were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.	Metastatic Melanoma Group Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
Overall Study Adverse Event	5	9
Overall Study Withdrawal by Subject	1	1
Overall Study Disease Progression	0	1

Baseline Characteristics

Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mRCC Group n=7 Participants Participants with mRCC were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.	Metastatic Melanoma Group n=19 Participants Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.	Total n=26 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 4.68 • n=5 Participants	51.3 years STANDARD_DEVIATION 12.08 • n=7 Participants	53.2 years STANDARD_DEVIATION 10.97 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Cycle 1, Day 1 to Cycle 2, Day 15

Population: The Pharmacokinetic Analysis (PK) set consisted of all participants in the safety set who completed two cycles of aldesleukin therapy and had evaluable post-baseline blood samples on Cycle 1, Day 1 and Cycle 2, Day 15. The Safety set consists of all participants who received at least one dose of aldesleukin and had at least one post-baseline safety assessment.

Outcome measures

Outcome measures
Measure	mRCC Group n=2 Participants Participants with mRCC were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.	Metastatic Melanoma Group n=11 Participants Participants with metastatic melanoma were administered aldesleukin 600,000 IU/kg (0.037 mg/kg) as a 15-minute IV infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy Participants With Presence of Anti-IL-2 antibodies (Anti-IL-2 Ab) Titer	60359.9 hour times picograms per mL(h × pg/mL) Standard Deviation 37406.04	173127.7 hour times picograms per mL(h × pg/mL) Standard Deviation 223655.01
Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy Participants With Absence of Anti-IL-2 Ab Titer	—	-22171.6 hour times picograms per mL(h × pg/mL) Standard Deviation 14798.46

Adverse Events

mRCC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Metastatic Melanoma

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 18627788300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	mRCC n=7 participants at risk mRCC	Metastatic Melanoma n=19 participants at risk Metastatic Melanoma
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	5.3% 1/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Cardiac disorders Atrial fibrillation	28.6% 2/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Gastrointestinal disorders Nausea	0.00% 0/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	5.3% 1/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	5.3% 1/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Infections and infestations Sepsis	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Investigations International normalised ratio increased	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Investigations Weight decreased	0.00% 0/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	5.3% 1/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Psychiatric disorders Confusional state	0.00% 0/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	5.3% 1/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Psychiatric disorders Mental status changes	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	5.3% 1/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Renal and urinary disorders Oliguria	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Renal and urinary disorders Renal failure	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Vascular disorders Hypotension	14.3% 1/7 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.	0.00% 0/19 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days. Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.