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NCT00009841 Clinical Trial

Gene Therapy in Treating Patients With Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase I Trial Of Intratumoral EGFR Antisense DNA And DC-Chol Liposomes In Advanced Oral Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00009841
Other study ID # PCI-98025
Secondary ID CDR0000068414PCI
Status Completed
Phase Phase 1
First received February 2, 2001
Last updated February 11, 2016
Start date March 1999
Est. completion date March 2002

Study information
Verified date June 2002
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date March 2002
Est. primary completion date March 2002
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility 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

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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• EGFR antisense DNA

• growth factor antagonist therapy

Drug:
• DC-cholesterol liposome

Locations
Country Name City State
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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