RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have advanced head and neck cancer.

Condition	Treatment or Intervention	Phase
lip and oral cavity cancer Head and Neck Cancer Oropharyngeal Cancer	Drug: DC-chol liposomes  Drug: EGFR antisense DNA	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the safety and biological activity of EGFR antisense DNA and DC-chol liposomes in patients with advanced squamous cell carcinoma of the head and neck. II. Determine the toxicity and maximum tolerated dose of this regimen in these patients. III. Determine the antitumor response in patients treated with this regimen. IV. Determine the effect of this regimen on EGFR expression levels, STAT protein expression/activation levels, and apoptosis rates in biopsied tumor cells of these patients.

PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive EGFR antisense DNA and DC-chol liposomes intratumorally weekly for 4 weeks. Courses repeat every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of EGFR antisense DNA and DC-chol liposomes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced squamous cell carcinoma of the head and neck Primary or recurrent disease; Not amenable to standard therapy (surgery, chemotherapy, or radiotherapy); Second primary lesions allowed
• Brain metastases allowed after definitive radiotherapy

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior biologic therapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 8 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT no greater than 4 times normal
• Renal: Creatinine no greater than 2 mg/dL; Calcium no greater than 10.5 mg/dL
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception (double-barrier method and oral contraception) prior to, during, and for at least 2 weeks after study

Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  United States

Study chairs or principal investigators

Jennifer Grandis,  Study Chair,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  CDR0000068414; PCI-98025; NCI-G00-1904; PCI-IRB-980771
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00009841
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08