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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

Page last updated: October 04, 2010

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