Trials / Unknown
UnknownNCT00041626
Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Introgen Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | INGN 201 |
Timeline
- First posted
- 2002-07-12
- Last updated
- 2007-09-11
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00041626. Inclusion in this directory is not an endorsement.