Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma - Full Text View

Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma

This study is not yet open for participant recruitment.
Verified by Novartis, July 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00414765

Purpose

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

Condition	Intervention	Phase
Metastatic Renal Cell Carcinoma Metastatic Melanoma	Drug: Aldesleukin	Phase I Phase II

MedlinePlus related topics:

Melanoma

ChemIDplus related topics:

Aldesleukin Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Pharmacokinetics of Aldesleukin

Secondary Outcome Measures:

no secondary outcome measures

Estimated Enrollment:	20
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414765

Contacts


Contact: Novartis	1 800 340 6843

Locations


United States, California
		Not yet recruiting
	Los Angeles, California, United States

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CPRL002A2201
First Received:	December 21, 2006
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00414765
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Metastatic Renal Cell Carcinoma

Metastatic Melanoma

Aldesleukin

IL-2

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Kidney cancer

Urologic Neoplasms

Melanoma

Carcinoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Aldesleukin

Urologic Diseases

Interleukin-2

Kidney Neoplasms

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Carcinoma, Renal Cell

Neuroepithelioma

Nevus

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms

Anti-HIV Agents

Neoplasms by Site

Neoplasms by Histologic Type

Anti-Retroviral Agents

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Nevi and Melanomas

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008