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Effectiveness and Safety of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone



Effectiveness and Safety of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone

For Condition: Carcinoma, Squamous Cell
Status: Recruiting
Sponsor(s): Introgen Therapeutics ,
Synopsis: There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - 18 years or older - Must have had radiation treatment - Eligible for chemotherapy - Not eligible for surgery
Total Enrollment: 

Location and Contact Information:

University of Arkansas *Recruiting*
Little Rock,  Arkansas, 
United States
Recruiting  


Additional Information:
Study ID Numbers:
  T302; 
Study Start Date: 
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041626

Other Carcinoma, Squamous Cell Studies:
1. An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck

2. Study Of Zd1839 (Iressaâ„¢) Versus Methotrexate For Previously Treated Patients With Squamous Cell Carcinoma Of The Head And Neck

3. Study to Compare the Overall Survival of Patients Receiving INGN 201 (study drug) with Patients Receiving Methotrexate

4. Effectiveness and Safety of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone

5. Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy

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Other Carcinoma, Squamous Cell Clinical Trials
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Effectiveness and Safety of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone

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