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



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

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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.
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 - Not eligible for surgery - Must have had radiation and chemotherapy treatments - No prior methotrexate treatments
Total Enrollment: 

Location and Contact Information:

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


Additional Information:
Study ID Numbers:
  T301; 
Study Start Date: 
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041613

Other Carcinoma, Squamous Cell Studies:
1. Study Of Zd1839 (Iressaâ„¢) Versus Methotrexate For Previously Treated Patients With Squamous Cell Carcinoma Of The Head And Neck

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

3. Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients

4. A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer

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

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