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TERMINATED
NCT01029873
PHASE1/PHASE2

QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

Sponsor: Altor BioScience

View on ClinicalTrials.gov

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

Interventions

DRUG

Cisplatin

Participants receive cisplatin 70 mg/m\^2 on cycle 1 day 1 only.

BIOLOGICAL

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