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

PHASE1TerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

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(5) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(5) spores/kg.

Trial Locations (2)

10461

Montefiore Medical Center, The Bronx

63110

Washington University School of Medicine, St Louis

Sponsors
All Listed Sponsors
lead

BioMed Valley Discoveries, Inc

INDUSTRY

NCT01118819 - Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies | Biotech Hunter | Biotech Hunter