Metastatic Melanoma, Metastatic Renal Cell Carcinoma
Conditions
Keywords
Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Aldesleukin, IL-2
Brief summary
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.
Interventions
DRUGAldesleukin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Performance Status Eastern Cooperative Oncology Group: 0 or 1. * Adequate organ function.
Exclusion criteria
* Pregnancy or lactation. * Prior treatment with any form of IL-2. * Organ transplant. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy | From Cycle 1, Day 1 to Cycle 2, Day 15 |
Countries
United States
Participant flow
Recruitment details
Participants took part at 4 investigative sites in the United States from 03-September-2008 to 28-March-2010.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| mRCC Group 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. | 7 |
| 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. | 19 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 9 |
| Overall Study | Disease Progression | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | mRCC Group | Metastatic Melanoma Group | Total |
|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 4.68 | 51.3 years STANDARD_DEVIATION 12.08 | 53.2 years STANDARD_DEVIATION 10.97 |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 15 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 19 |
| other Total, other adverse events | 0 / 7 | 0 / 19 |
| serious Total, serious adverse events | 3 / 7 | 4 / 19 |
Outcome results
Primary
Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mRCC Group | 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 |
| Metastatic Melanoma Group | 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 | 173127.7 hour times picograms per mL(h × pg/mL) | Standard Deviation 223655.01 |
| Metastatic Melanoma Group | 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 |