Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .
All accrued subjects will be randomized 2:1 to AlloVax™ (CRCL + AlloStim™) immunotherapy vs. standard chemotherapy. AlloVax™ is an experimental individualized therapeutic vaccine shown to be active in this study population. The standard chemotherapy arm (Arm 1) will receive up to six three-week cycles of chemotherapy consisting of cisplatin on day 0 of the 3-week cycle at dose 80-100 mg/m2 IV followed by 1000 mg/m2 IV flurouracil (5FU) on days 1-4 of the cycle. The immunotherapy arm (Arm 2) will receive immunotherapy (AlloVax™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks. The study is designed and powered to determine if AlloVax™ is not inferior to the active chemotherapy control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens
Subjects in the chemotherapy arm will receive up to 6 cycles of cisplatin on day 0 of the 3-week cycle at dose of 80-100 mg/m2 IV and 1000 mg/m2 IV 5FU on days 1-4 of the cycle
National Cancer Institute of Thailand
Bangkok, Thailand
Safety and tolerability (vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT))
Whether AlloVax™ is less toxic than chemotherapy. will be evaluated on the basis of the following parameters: vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)
Time frame: 119 days
Overall Survival
Whether AlloVax™ is not inferior to the active chemotherapy control (from time of randomization). Subjects are followed for survival during the trial and as long as they are alive after the last study treatment through follow-up
Time frame: 119 days
Health related Quality of Life (HRQoL)
QLQ-C30 and QLQ-H\&N35 questionnaires
Time frame: 119 days
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