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Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma; Metastatic Melanoma

Intervention: Aldesleukin (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


This study will evaluate the pharmacokinetics of aldesleukin in patients with metastatic renal cell cancer and metastatic melanoma

Clinical Details

Official title: Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma and Metastatic Melanoma With Immunologic Correlative Studies

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetics of Aldesleukin


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion criteria:

- Performance Status Eastern Cooperative Oncology Group: 0 or 1

- Adequate organ function

Exclusion criteria:

- Pregnancy or lactation

- Prior treatment with aldesleukin

- Organ transplant Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

USC/Kenneth Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States

University of Colorado Cancer Center, Aurora, Colorado 80045, United States

James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Additional Information

Starting date: January 2006
Last updated: February 9, 2013

Page last updated: August 23, 2015

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