Head and Neck Cancer Clinical Trial
Official title:
Protocol IL-2001: A Multi-Center, Open-Label, Randomized Study of the Efficacy and Safety of Multiple Intratumoral Injections of hIl-2 Plasmid (1.8 mg) Formulated With DOTMA/Cholesterol [Ratio 1:0.5(-/+)] Liposomes in Patients With Unresctable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Inserting the gene for interleukin-2 into head and neck cancer cells may make the
body build an immune response to kill the tumor cells. Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop growing or die. It is not yet
known whether the interleukin-2 gene is more effective than methotrexate for advanced head
and neck cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of the interleukin-2 gene
with that of methotrexate in treating patients who have recurrent or refractory stage III or
stage IV head and neck cancer.
OBJECTIVES: I. Compare the efficacy of interleukin-2 gene versus methotrexate in patients
with recurrent or refractory squamous cell carcinoma of the head and neck. II. Determine the
safety and tolerability of interleukin-2 gene in these patients. III. Compare the quality of
life of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive interleukin-2 gene intratumorally on days 1 and 4 of
week 1, and then once weekly for 12 weeks in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive methotrexate IV once weekly. Treatment
continues in the absence of disease progression or unacceptable toxicity. Quality of life is
assessed at the beginning of the study and at weeks 5, 13, 17 and 25. Patients are followed
every 2-3 weeks for up to 18 weeks.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study.
;
Primary Purpose: Treatment
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