Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

October 31, 2017

Study Completion Date

October 31, 2017

Conditions
Solid Tumor Malignancies
Interventions
BIOLOGICAL

Clostridium novyi-NT spores

Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 x 10(4) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(4) spores/kg.

Trial Locations (5)

10021

Memorial Sloan Kettering Cancer Center, New York

10461

Albert Einstein College of Medicine, The Bronx

44195

Cleveland Clinic Foundation, Cleveland

63110

Washington University School of Medicine, St Louis

77030

UT M.D. Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

BioMed Valley Discoveries, Inc

INDUSTRY

NCT01924689 - Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies | Biotech Hunter | Biotech Hunter