Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

Novartis

Status and phase: Completed; Phase 4

Conditions: Metastatic Renal Cell Carcinoma; Metastatic Melanoma

Treatments: Drug: Aldesleukin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414765

CPRL002A2201

Details and patient eligibility

About

This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Performance Status Eastern Cooperative Oncology Group: 0 or 1.
• Adequate organ function.

Exclusion criteria

• Pregnancy or lactation.
• Prior treatment with any form of IL-2.
• Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Aldesleukin

Experimental group

Description:

All participants were treated with aldesleukin 600,000 international units per kilogram \[IU/kg\] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.

Treatment:

Drug: Aldesleukin