Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
I. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1
and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node
II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1
and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.
III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by
IV. To compare the clinical responses and safety profile of patients with cutaneous tumors
and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM
I. To establish evidence of host anti-tumor immune reactivity following intra-lesional
vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients
with cutaneous tumors and visceral tumors.
II. To evaluate the quality of life during vaccine administration.
OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified
according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral
metastases). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity. Patients with stable or responding disease may receive
Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each
treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then
6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6
patients experience DLT, then 12 patients from the visceral disease (VD) stratum are
randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then
the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original
12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If
no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose
Quality of life is assessed at baseline, monthly during therapy, and then at the end of
Patients are followed every 3 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentages of the DLTEs
Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
Mount Sinai School of Medicine
United States: Food and Drug Administration
|Mount Sinai Medical Center||New York, New York 10029|