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Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00041613
Enrollment
Unknown
Registered
2002-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2008-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell

Keywords

Refractory Squamous Cell Carcinoma of the Head and Neck

Brief 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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Interventions

GENETICINGN 201

Sponsors

Introgen Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * Not eligible for surgery * Must have had radiation and chemotherapy treatments * No prior methotrexate treatments

Countries

United States

Contacts

Primary ContactIntrogen Therapeutics, Inc.
clinicaltrials@introgen.com866.631.4646
Backup ContactTherapeutics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026