Clinical Trials Logo
  1. Home
  2. Metastatic Melanoma
  3. NCT00414765
  4. Details
NCT00414765 Clinical Trial

Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:
Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00414765
Other study ID # CPRL002A2201
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 3, 2008
Est. completion date March 28, 2010

Study information
Verified date June 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date March 28, 2010
Est. primary completion date March 28, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aldesleukin

Locations
Country Name City State
United States University of Colorado Cancer Center Aurora Colorado
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States USC/Kenneth Norris Comprehensive Cancer Center Los Angeles California
United States James Graham Brown Cancer Center Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02224781 - Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma Phase 3
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Recruiting NCT05388877 - E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma Phase 1
Active, not recruiting NCT05103891 - Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations Phase 1
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Completed NCT01621490 - PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma Phase 1
Recruiting NCT05779423 - Cryoablation+Ipilimumab+Nivolumab in Melanoma Phase 2
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT02278887 - Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma Phase 3
Active, not recruiting NCT02360579 - Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma Phase 2
Terminated NCT02521870 - A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 1/Phase 2
Completed NCT02177110 - A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
Withdrawn NCT01340729 - Open-Label Study of TPI 287 for Patients With Metastatic Melanoma Phase 1/Phase 2
Withdrawn NCT01416844 - Study of Immune Responses in Patients With Metastatic Melanoma Phase 2
Terminated NCT01468818 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma Phase 2
Completed NCT00984464 - Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma Phase 2
Completed NCT00631618 - Clinical Trial of Sutent to Treat Metastatic Melanoma Phase 2
Terminated NCT00571116 - Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy Phase 1
Recruiting NCT00226473 - Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma Phase 4
Active, not recruiting NCT04967196 - Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma Phase 1