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Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat Clinical research trials and Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat. Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat clinical trial. Subjects frequently get the best healthcare possible for their Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat
Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat
For Condition: stage 3 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the oropharynx
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the feasibility of treating patients with newly diagnosed resectable stage III or IV squamous cell carcinoma of the oral cavity or oropharynx 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 months for 5 years. In the event of disease progression, patients are followed every 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-risk/limited stage III or IV squamous cell carcinoma of the oral cavity or oropharynx - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeYoo, Study Chair, Barbara Ann Karmanos Cancer Institute
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Joseph Brennan 210-916-0504
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Wolfram Samlowski 801-585-0255
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Greg Krempl 405-271-6673
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting George Yoo 313-745-4700
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0293
United States
Recruiting Joseph Valentino 859-257-4500
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting David Schuller 614-293-4878
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0502
United States
Recruiting Lyon Gleich 513-584-3200
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205-7199
United States
Recruiting Ehab Hanna 501-686-5140
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Guy Petruzelli 708-216-9183
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7380
United States
Recruiting Douglas Girod 913-588-6722
Additional Information:
Study ID Numbers: CDR0000068658; SWOG-S0011
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017173
Other Stage 4 Squamous Cell Carcinoma Of The Lip And Oral Cavity Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
2. Chemotherapy With or Without Docetaxel Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
4. Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
5. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Related Studies:
Other stage 4 squamous cell carcinoma of the lip and oral cavity Clinical Trials
Other Oklahoma Clinical Trials
Other Oklahoma City Clinical Trials
Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat
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