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QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma
Sponsor: Altor BioScience
Summary
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.
Official title: Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2010-02
Completion Date
2013-09
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Cisplatin
Participants receive cisplatin 70 mg/m\^2 on cycle 1 day 1 only.
ALT-801
Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.10 mg/kg) Stage 2: dose expansion (dose at MTD)
Locations (8)
The Angeles Clinic and Research Institute
Los Angeles, California, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Carolinas Medical Center-Brumenthal Cancer Center
Charlotte, North Carolina, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States
University of Washington, Seattle Cancer Care Center
Seattle, Washington, United States