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Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414765
First Posted: December 22, 2006
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
December 21, 2006
December 22, 2006
February 12, 2013
January 2006
March 2010   (Final data collection date for primary outcome measure)
Pharmacokinetics of Aldesleukin [ Time Frame: over 19 days (4 PK assessments (blood) ]
Pharmacokinetics of Aldesleukin
Complete list of historical versions of study NCT00414765 on ClinicalTrials.gov Archive Site
Not Provided
no secondary outcome measures
Not Provided
Not Provided
 
Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma
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
This study will evaluate the pharmacokinetics of aldesleukin in patients with metastatic renal cell cancer and metastatic melanoma
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Metastatic Renal Cell Carcinoma
  • Metastatic Melanoma
Drug: Aldesleukin
Other Names:
  • Proleukin,
  • PRL002
Experimental: Aldesleukin
Intervention: Drug: Aldesleukin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Not Provided
March 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00414765
CPRL002A2201
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP