Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
PRIMARY OBJECTIVES:
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
metastatic tumors.
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
intra-tumoral injection.
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
vaccine.
SECONDARY OBJECTIVES:
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
additional courses.
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
treatment.
Quality of life is assessed at baseline, monthly during therapy, and then at the end of
therapy.
Patients are followed every 3 months.
Interventional
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.
12 weeks
Yes
Howard Kaufman
Principal Investigator
Mount Sinai School of Medicine
United States: Food and Drug Administration
NCI-2012-02455
NCT00030693
December 2001
Name | Location |
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Mount Sinai Medical Center | New York, New York 10029 |