Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

NCT ID: NCT00414765

Last Updated: 2021-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-03

Study Completion Date

2010-03-28

Brief Summary

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

Detailed Description

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Conditions

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Metastatic Renal Cell Carcinoma Metastatic Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aldesleukin

Intervention Type DRUG

Interventions

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Aldesleukin

Intervention Type DRUG

Other Intervention Names

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Proleukin® PRL002

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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USC/Kenneth Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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CPRL002A2201

Identifier Type: -

Identifier Source: org_study_id

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