Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 800-340-6843
Summary
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: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics of Aldesleukin
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Novartis Pharmaceuticals, Phone: 800-340-6843
USC/Kenneth Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Not yet recruiting
David Quinn, M.D., Email: quinn_d@ccnt.usc.edu
David Quinn, M.D., Principal Investigator
University of Colorado Cancer Center, Aurora, Colorado 80045, United States; Recruiting
Karl Lewis, M.D., Email: karllewis@uchsc.edu
Karl Lewis, M.D, Principal Investigator
James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States; Recruiting
Jason Chesny, M.D., Email: jason.chesny@louisville.edu
Jason Chesny, M.D., Principal Investigator
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Not yet recruiting
Marc Ernstoff, M.D., Email: marc.s.ernstoff@hitchcock.org
Marc Ernstoff, M.D., Principal Investigator
Additional Information
Starting date: January 2006
Last updated: November 18, 2009
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