Phase I Trial Of Intratumoral EGFR Antisense DNA And DC-Chol Liposomes In Advanced Oral Squamous Cell Carcinoma
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase I Trial Of Intratumoral EGFR Antisense DNA And DC-Chol Liposomes In Advanced Oral Squamous Cell Carcinoma
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jennifer R. Grandis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Federal Government
Study ID:
CDR0000068414
NCT ID:
NCT00009841
Start Date:
March 1999
Completion Date:
Related Keywords:
- Head and Neck Cancer
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage IV squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
