Phase II Trial Of Surgery With Perioperative RPR/INGN 201 (Ad5CMV-p53) Gene Therapy Followed By Chemoradiotherapy For Advanced, Resectable Squamous Cell Carcinoma Of The Oral Cavity, Oropharynx, Larynx, and Pharynx
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase II Trial Of Surgery With Perioperative RPR/INGN 201 (Ad5CMV-p53) Gene Therapy Followed By Chemoradiotherapy For Advanced, Resectable Squamous Cell Carcinoma Of The Oral Cavity, Oropharynx, Larynx, and Pharynx
OBJECTIVES:
- Determine the feasibility of treating patients with newly diagnosed resectable stage
III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or
larynx with surgery and Ad5CMV-p53 gene followed by cisplatin and radiotherapy.
- Determine the progression-free survival, local control, and overall survival of
patients treated with this regimen.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo surgical resection and receive an intraoperative Ad5CMV-p53 gene injection
into the resection bed and into the deep soft tissue bed of the cervical level with nodal
metastasis. Patients also receive a third intraoperative Ad5CMV-p53 gene injection into the
neck dissection bed, where it is allowed to sit in place for 10 minutes.
Within 48-72 hours after surgery, patients receive a postoperative Ad5CMV-p53 gene injection
into each of two drainage catheters next to the mucosal suture line and neck dissection bed,
where it is allowed to sit in place for 2 hours.
Within 56 days after surgery, patients receive cisplatin IV over 30-90 minutes on days 1,
22, and 43 and radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients may
receive 3 additional days of radiotherapy to high-risk areas on days 43-45.
Patients are followed every 2-6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed high-risk/limited stage III or IV squamous cell carcinoma of
the oral cavity, oropharynx, hypopharynx, and larynx
- Newly diagnosed
- Previously untreated
- Considered surgically resectable
- Evidence of regional lymph node metastases (N1-N3)
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 3 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal:
- Creatinine no greater than 2 times ULN
- Creatinine clearance at least 60 mL/min
Other:
- Magnesium normal (magnesium supplement allowed)
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission
- HIV negative
- Not pregnant or nursing
- Patients must use effective barrier contraception and prevent bodily fluid
transmission during and for 28 days after Ad5CMV-p53 gene administration
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No concurrent intensity-modulated radiotherapy
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Description:
accrual rate and percentage of patients successfully receiving the required doses of INGN 201
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
George H. Yoo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068658
NCT ID:
NCT00017173
Start Date:
February 2003
Completion Date:
July 2011
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV verrucous carcinoma of the larynx
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Mouth Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
