Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

NCT00414765 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CPRL002A2201
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Metastatic Renal Cell Carcinoma; Metastatic Melanoma

Keywords

Metastatic Renal Cell Carcinoma; Metastatic Melanoma; Aldesleukin; IL-2

Outcome Measures

Primary Outcomes (1)

• Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy

  From Cycle 1, Day 1 to Cycle 2, Day 15

Study Arms (1)

Aldesleukin

EXPERIMENTAL

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.

Drug: Aldesleukin

Interventions

Aldesleukin DRUG

Also known as: Proleukin®, PRL002

Aldesleukin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or lactation.
• Prior treatment with any form of IL-2.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

USC/Kenneth Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Melanoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

18627788300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: September 3, 2008
• Primary Completion: March 28, 2010
• Study Completion: March 28, 2010
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-06

Locations

US (4)