Phase I Study of gp75 DNA Vaccine in Patients With AJCC Stage III and IV Melanoma
This study is designed to evaluate the safety and feasibility of intramuscular vaccination
with gp75 DNA in patients with stage III or IV melanoma. Secondary objectives are to
observe the patient for any evidence of anti-tumor response and to establish the optimal
biologically effective dose. Up to 24 evaluable patients with stage III or IV metastatic
melanoma or with stage III melanoma, currently disease-free, but at high risk for recurrence
will be enrolled. Patients will be be enrolled into an assigned dose group and will receive
five vaccinations of gp75. In order for dose escalation to proceed, only one patient in the
current dose group may have demonstrated a dose limiting toxicity (DLT). If a second
patient experiences such toxicity then both patients will move down to the previous dose
level, and the previous dose level will be considered to be the MTD. If no DLTs are
encountered, patients will continue on study at the assigned dose level. Any patient
experiencing a DLT will not receive further vaccination until the toxicity has resolved.
Patients exhibiting both serological and stable/clinical response after receiving the fifth
vaccination will be eligible to receive booster vaccinations. An additional patient will be
accrued to the dose level for every patient that progresses prior to the fifth vaccination.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety and feasibility of intramuscular vaccination with gp75 DNA in patients with stage III or IV melanoma.
E-mail: ClinicalTrials@ ImClone.com
United States: Food and Drug Administration
|ImClone Investigational Site||New York, New York 10021|