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Chemotherapy With or Without Gene Therapy in Treating Patients With Unresectable Recurrent Head and Neck Cancer



Chemotherapy With or Without Gene Therapy in Treating Patients With Unresectable Recurrent Head and Neck Cancer

For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): Introgen Therapeutics ,
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for p53 into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. It is not yet known whether chemotherapy is more effective with or without gene therapy in treating recurrent head and neck cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy with or without gene therapy in treating patients who have unresectable recurrent head and neck cancer.
Details: OBJECTIVES: - Compare the time to loco-regional and overall disease progression in patients with unresectable recurrent squamous cell carcinoma of the head and neck treated with cisplatin and fluorouracil with or without Ad5CMV-p53 gene therapy (INGN 201). OUTLINE: Not specified PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed recurrent squamous cell carcinoma of the head and neck - Local or regional disease recurrence after first-line therapy with curative intent - Any number of prior recurrences allowed - Must have received at least 5,000 cGy of standard method radiotherapy - Must be ineligible for standard radiotherapy or complete resection at recurrence - Must be eligible to receive a minimum of 4 courses of chemotherapy - Prior exposure to platinum or fluorouracil allowed provided this therapy is still appropriate PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior gene therapy with adenoviral vectors or p53 gene product Chemotherapy: - See Disease Characteristics - More than 4 weeks since prior systemic chemotherapy Endocrine therapy: - No more than 6 months of prior chronic non-topical corticosteroids (prednisone or equivalent) at doses over 10 mg/day Radiotherapy: - See Disease Characteristics - More than 8 weeks since prior radiotherapy for loco-regional disease Surgery: - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DonnaCall,  Study Chair,  Introgen Therapeutics

Introgen Therapeutics, Incorporated *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Donna  Call 713-610-4021


Additional Information:
Study ID Numbers:
  CDR0000069392;  INTROGEN-T302
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040716

Other Head And Neck Cancer Studies:
1. Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer

2. EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer

3. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery

4. Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

5. Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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Chemotherapy With or Without Gene Therapy in Treating Patients With Unresectable Recurrent Head and Neck Cancer

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