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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 )
  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 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Pharmacokinetics of Aldesleukin [ Time Frame: over 19 days (4 PK assessments (blood) ]

Enrollment: 26
Study Start Date: January 2006
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aldesleukin Drug: Aldesleukin
Other Names:
  • Proleukin,
  • PRL002

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414765


Locations
United States, California
USC/Kenneth Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00414765     History of Changes
Other Study ID Numbers: CPRL002A2201
First Submitted: December 21, 2006
First Posted: December 22, 2006
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Metastatic Renal Cell Carcinoma
Metastatic Melanoma
Aldesleukin
IL-2

Additional relevant MeSH terms:
Carcinoma
Melanoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs


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