A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients
- Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine
in patients with stage IV melanoma.
- Determine the safety and tolerability of this drug in these patients.
- Determine the immunological response, as measured by changes in frequency of T cells
specific against vaccine-encoded epitopes before and after treatment, in patients
treated with this drug.
- Determine the clinical response, as measured by lactic dehydrogenase levels and
radiologic assessment of lesions, in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on
days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable
toxicity. Patients with evidence of stable or responding disease are eligible for 4
additional courses of treatment.
Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 10 days after the last dose of study drug.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.
Chief Scientific Officer
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|
|Cancer Research Center at Boston Medical Center||Boston, Massachusetts 02118|
|Earle A. Chiles Research Institute at Providence Portland Medical Center||Portland, Oregon 97213-2967|