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Phase II Study of Surgery and Ad5CMV-p53 Gene Followed By Cisplatin and Radiotherapy in Patients With Newly Diagnosed Resectable Stage III or IV Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

18 and over

NCI

SWOG-S0011
S0011, NCT00017173

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

No concurrent intensity-modulated radiotherapy

Surgery:

Not specified

Patient Characteristics:

Age:

18 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm³
Granulocyte count at least 1,500/mm³
Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 60 patients will be accrued for this study within 1 year.

Outcomes

Primary Outcome(s)

Feasibility of treatment as measured by accrual rate and percentage of patients successfully receiving the required doses of study treatment to the primary site

Secondary Outcome(s)

Progression-free survival from time of registration until disease progression
Overall survival from time of registration until death from any cause
Local control assessed from time of registration until disease progression within 2 cm of initial primary/nodal disease
Toxicity of Ad5CMV-p53 gene (INGN 201) and chemoradiation assessed from time of registration until 30 days after completion of study treatment

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

George Yoo, MD, Protocol chair
Ph: 313-745-4336; 800-527-6266
Email: gyoo@med.wayne.edu

Registry Information

Official Title		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

Trial Start Date		2003-02-06

Registered in ClinicalTrials.gov		NCT00017173

Date Submitted to PDQ		2001-04-09

Information Last Verified		2006-05-25

NCI Grant/Contract Number		CA32102

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.