A Phase I/II Study With CEA(6D) VRP Vaccine in Patients With Advanced or Metastatic CEA-Expressing Malignancies

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
Colorectal CancerBreast CancerLung CancerPancreatic CancerColon Cancer
Interventions
BIOLOGICAL

AVX701

4 doses of AVX701 at 4e7 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease

BIOLOGICAL

AVX701

4 doses of AVX701 at 1e8 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease

BIOLOGICAL

AVX701

4 doses of AVX701 at 4e8 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease

BIOLOGICAL

AVX701

4 doses of AVX701 given at the maximally tolerated dose at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease

BIOLOGICAL

AVX701

4 Doses of AVX701 given to Stage III colon cancer subjects at the maximally tolerated dose at T=0, 3, 6, 9 weeks. There will be no option for subjects to receive additional immunizations.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

lead

AlphaVax, Inc.

INDUSTRY