search
Back to results

Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

Primary Purpose

Metastatic Renal Cell Carcinoma, Metastatic Melanoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Aldesleukin, IL-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Kenneth Norris Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • James Graham Brown Cancer Center
  • Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aldesleukin

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy

Secondary Outcome Measures

Full Information

First Posted
December 21, 2006
Last Updated
June 4, 2021
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00414765
Brief Title
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2008 (Actual)
Primary Completion Date
March 28, 2010 (Actual)
Study Completion Date
March 28, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma, Metastatic Melanoma
Keywords
Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Aldesleukin, IL-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aldesleukin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
Other Intervention Name(s)
Proleukin®, PRL002
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
USC/Kenneth Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

We'll reach out to this number within 24 hrs