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

Introgen Therapeutics

Status and phase: Unknown; Phase 3

Conditions: Carcinoma, Squamous Cell

Treatments: Genetic: INGN 201

Study type: Interventional

Funder types: Industry

Identifiers

NCT00041626

T302

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 18 years or older
• Must have had radiation treatment
• Eligible for chemotherapy
• Not eligible for surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)