Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00414765
• Collaborator: (none)
• Enrollment: 26
• Locations: 4
• Arm: 1
• Actual Duration (Months): 18.8
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma; Metastatic Melanoma	Drug: Aldesleukin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies
• Actual Study Start Date: Sep 3, 2008
• Actual Primary Completion Date: Mar 28, 2010
• Actual Study Completion Date: Mar 28, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Aldesleukin All participants were treated with aldesleukin 600,000 international units per kilogram [IU/kg] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (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.

Drug: Aldesleukin; Other Names: Proleukin® PRL002

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Kenneth Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
2	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
3	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202
4	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00414765
• Other Study ID Numbers: CPRL002A2201
• First Posted: Dec 22, 2006
• Last Update Posted: Jun 8, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Metastatic Renal Cell Carcinoma; Metastatic Melanoma; Aldesleukin; IL-2
• Additional relevant MeSH terms: Carcinoma; Melanoma; Carcinoma, Renal Cell; Aldesleukin

Study Results

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 Detail	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.

Arm/Group Title	mRCC Group	Metastatic Melanoma Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	7	19
Completed Study	7	18
Completed Cycle 1	7	19
Completed Cycle 2	4	16
COMPLETED	1	8
NOT COMPLETED	6	11

Baseline Characteristics

Arm/Group Title	mRCC Group	Metastatic Melanoma Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	7	19	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.3 (4.68)	51.3 (12.08)	53.2 (10.97)
Sex: Female, Male (Count of Participants)
Female	2 28.6%	4 21.1%	6 23.1%
Male	5 71.4%	15 78.9%	20 76.9%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

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/Group Title	mRCC Group	Metastatic Melanoma Group
Arm/Group Description	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.	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.
Measure Participants	2	11
Participants With Presence of Anti-IL-2 antibodies (Anti-IL-2 Ab) Titer	60359.9 (37406.04)	173127.7 (223655.01)
Participants With Absence of Anti-IL-2 Ab Titer	-22171.6 (14798.46)

Adverse Events

Time Frame	Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days.
Adverse Event Reporting Description	Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
Arm/Group Title	mRCC		Metastatic Melanoma
Arm/Group Description	mRCC		Metastatic Melanoma
All Cause Mortality
	mRCC		Metastatic Melanoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/19 (0%)
Serious Adverse Events
	mRCC		Metastatic Melanoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		4/19 (21.1%)
Blood and lymphatic system disorders
Thrombocytopenia	0/7 (0%)		1/19 (5.3%)
Cardiac disorders
Atrial fibrillation	2/7 (28.6%)		0/19 (0%)
Gastrointestinal disorders
Nausea	0/7 (0%)		1/19 (5.3%)
Vomiting	0/7 (0%)		1/19 (5.3%)
Infections and infestations
Sepsis	1/7 (14.3%)		0/19 (0%)
Investigations
International normalised ratio increased	1/7 (14.3%)		0/19 (0%)
Weight decreased	0/7 (0%)		1/19 (5.3%)
Psychiatric disorders
Confusional state	0/7 (0%)		1/19 (5.3%)
Mental status changes	1/7 (14.3%)		1/19 (5.3%)
Renal and urinary disorders
Oliguria	1/7 (14.3%)		0/19 (0%)
Renal failure	1/7 (14.3%)		0/19 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/7 (14.3%)		0/19 (0%)
Dyspnoea	1/7 (14.3%)		0/19 (0%)
Respiratory failure	1/7 (14.3%)		0/19 (0%)
Vascular disorders
Hypotension	1/7 (14.3%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	mRCC		Metastatic Melanoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.