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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 InstituteDetroit, Michigan  48201
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084