A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

September 6, 2011

Primary Completion Date

April 11, 2016

Study Completion Date

April 11, 2016

Conditions
Transitional Cell Carcinoma of BladderUrethra CancerUreter CancerMalignant Tumor of Renal Pelvis
Interventions
DRUG

Cisplatin

Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)

DRUG

Gemcitabine

Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course

BIOLOGICAL

ALT-801

Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course

Trial Locations (16)

15232

UPMC Cancer Center, Pittsburgh

18045

St. Luke's Hospital and Health Network, Easton

19107

Thomas Jefferson University Hospital, Philadelphia

28203

Levine Cancer Institute, Charlotte

30322

Emory University, Atlanta

32806

UF Health Center at Orlando Health, Orlando

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

34994

Martin Health System, Stuart

48201

Karmanos Cancer Center, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

55455

University of Minnesota, Minneapolis

60611

Robert Lurie Comprehensive Cancer Center of Northwestern University, Chicago

63110

Washington University, St Louis

66205

University of Kansas Cancer Center, Fairway

73104

University of Oklahoma Health Science Center, Oklahoma City

85724

The University of Arizona Cancer Center, Tucson

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Altor BioScience

INDUSTRY

NCT01326871 - A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer | Biotech Hunter | Biotech Hunter