Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
RATIONALE: Inserting the gene for interleukin-12 into a person's cancer cells may make the body build an immune response to kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
|Study Start Date:||July 1999|
OBJECTIVES: I. Determine the safety and tolerability of interleukin-12 gene in patients with unresectable, recurrent, or refractory squamous cell carcinoma of the head and neck. II. Evaluate the efficacy of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive interleukin-12 gene by intratumoral injection twice during week 1 and once weekly during weeks 2-7 in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 28-34 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004070
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||A. Dimitrios Colevas, MD||NCI - Investigational Drug Branch|