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S0011, Gene Therapy & Surgery Followed by Chemo & RT in Newly Diagnosed Cancer of the Mouth or Throat

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ClinicalTrials.gov Identifier: NCT00017173
Recruitment Status : Terminated (Terminated for poor accrual.)
First Posted : January 27, 2003
Last Update Posted : June 14, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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Brief Summary:

RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by cisplatin and radiation therapy in treating patients who have newly diagnosed resectable stage III or stage IV cancer of the mouth or throat.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: Ad5CMV-p53 gene Drug: cisplatin Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: surgery with INGN 201 followed by chemo/RT
intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy
 Biological: Ad5CMV-p53 gene
2 intraoperative and one post-operative injection of Ad5CMV-p53.
Other Name: INGN 201

Drug: cisplatin
100 mg/m2 IV Day 1 every 21 days for 3 cycles
Other Name: platinol

Procedure: conventional surgery
conventional surgery
Other Name: surgery

Radiation: radiation therapy
200 cGy per day Days 105 every week for 6 weeks
Other Name: RT


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility [ Time Frame: 1 year ]
    accrual rate and percentage of patients successfully receiving the required doses of INGN 201


Secondary Outcome Measures :
  1. Progression-free survival from time of registration until disease progression [ Time Frame: two years ]
    percentage of patient who have not experience progression of disease at two years


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017173


Locations
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: George H. Yoo, MD Barbara Ann Karmanos Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00017173     History of Changes
Other Study ID Numbers: CDR0000068658
U10CA032102 ( U.S. NIH Grant/Contract )
S0011 ( Other Identifier: SWOG )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Southwest Oncology Group:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antineoplastic Agents