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Comparison of Gene Therapy With Chemotherapy in Treating Patients With Head and Neck Cancer



Comparison of Gene Therapy With Chemotherapy in Treating Patients With Head and Neck Cancer

For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): Introgen Therapeutics ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p-53 gene into a person's cancer cells may improve the body's ability to fight cancer. It is not yet known if gene therapy is more effective than chemotherapy in treating head and neck cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of gene therapy with that of chemotherapy in treating patients who have head and neck cancer that has not responded to previous treatment.
Details: OBJECTIVES: - Compare the overall survival in patients with refractory squamous cell carcinoma of the head and neck treated with Ad5CMV-p53 gene therapy (INGN 201) vs methotrexate. 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 confirmed recurrent or progressive primary squamous cell carcinoma of the head and neck - Unresectable disease - At least 5,000 cGy of prior standard method radiotherapy - Failed at least one chemotherapy regimen containing either a platinum or a taxane PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - 4 months 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 - No prior autologous or allogeneic organ or tissue transplantation Chemotherapy: - 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: - 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:
  CDR0000069391;  INTROGEN-T301
Study Start Date: 
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040703

Other Head And Neck Cancer Studies:
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2. Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

3. Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel

4. Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer

5. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer

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Comparison of Gene Therapy With Chemotherapy in Treating Patients With Head and Neck Cancer

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