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
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Renal Cell Carcinoma, Metastatic Melanoma
Both
Metastatic Renal Cell Carcinoma, Metastatic Melanoma
Trial Information
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetics of Aldesleukin
Outcome Time Frame:
over 19 days (4 PK assessments (blood)
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CPRL002A2201
NCT ID:
NCT00414765
Start Date:
January 2006
Completion Date:
Related Keywords:
- Metastatic Renal Cell Carcinoma
- Metastatic Melanoma
- Metastatic Renal Cell Carcinoma
- Metastatic Melanoma
- Aldesleukin
- IL-2
- Carcinoma
- Carcinoma, Renal Cell
- Melanoma
Name | Location |
|---|---|
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| USC/Kenneth Norris Comprehensive Cancer Center | Los Angeles, California 90033 |
