Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00414765
First received: December 21, 2006
Last updated: February 9, 2013
Last verified: February 2013
  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: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Pharmacokinetics of Aldesleukin [ Time Frame: over 19 days (4 PK assessments (blood) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00414765     History of Changes
Other Study ID Numbers: CPRL002A2201
Study First Received: December 21, 2006
Last Updated: February 9, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014