Study of gp75 Vaccine in Patients With Stage III and IV Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

September 30, 2004

Study Completion Date

September 30, 2004

Conditions
Malignant Melanoma
Interventions
BIOLOGICAL

gp75 DNA vaccine

6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5\* patient safely completing the 2nd vaccination at the lower dose level.

Trial Locations (1)

10021

ImClone Investigational Site, New York

All Listed Sponsors
collaborator

Memorial Sloan Kettering Cancer Center

OTHER

lead

Eli Lilly and Company

INDUSTRY

NCT00034554 - Study of gp75 Vaccine in Patients With Stage III and IV Melanoma | Biotech Hunter | Biotech Hunter