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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
Not Enrolling
Both
Metastatic Renal Cell Carcinoma, Metastatic Melanoma

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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 CenterDenver, Colorado  80262
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
USC/Kenneth Norris Comprehensive Cancer CenterLos Angeles, California  90033