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Home > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Advanced Head and Neck Cancer  Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
For Condition: Head and Neck Cancer,lip and oral cavity cancer,Oropharyngeal Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JenniferGrandis, Study Chair, University of Pittsburgh Cancer Institute
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Additional Information:
Study ID Numbers: CDR0000068414; PCI-IRB-980771,NCI-G00-1904,PCI-98025
Study Start Date: March 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009841
Other Head And Neck Cancer Studies:
1. Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
2. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
3. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
4. Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
5. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
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