Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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: 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
USC/Kenneth Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States
University of Colorado Cancer Center, Aurora, Colorado 80045, United States
James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States
Additional Information
Starting date: January 2006
Last updated: February 9, 2013
|
