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Phase III Randomized Study of Ad5CMV-p53 Gene Therapy (INGN 201) Versus Methotrexate in Patients With Refractory Squamous Cell Carcinoma of the Head and Neck (T301)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Gene Therapy With Chemotherapy in Treating Patients With Head and Neck Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Active

18 and over

Pharmaceutical / Industry

INTROGEN-T301
NCT00041613

Objectives

Compare the overall survival in patients with refractory squamous cell carcinoma of the head and neck treated with Ad5CMV-p53 gene therapy (INGN 201) vs methotrexate.

Entry Criteria

Disease Characteristics:

Histologically confirmed recurrent or progressive primary squamous cell carcinoma of the head and neck
- Unresectable disease

At least 5,000 cGy of prior standard method radiotherapy

Failed at least one chemotherapy regimen containing either a platinum or a taxane

Prior/Concurrent Therapy:

Biologic therapy:

No prior gene therapy with adenoviral vectors or p53 gene product
No prior autologous or allogeneic organ or tissue transplantation

Chemotherapy:

More than 4 weeks since prior systemic chemotherapy

Endocrine therapy:

No more than 6 months of prior chronic non-topical corticosteroids (prednisone or equivalent) at doses over 10 mg/day

Radiotherapy:

More than 8 weeks since prior radiotherapy for loco-regional disease

Surgery:

Not specified

Patient Characteristics:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

4 months

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant or nursing

Expected Enrollment

Not specified

Outcomes

Primary Outcome(s)

Time to death

Secondary Outcome(s)

Locoregional tumor growth and locoregional response rate
Time to locoregional disease progression
Overall tumor growth and objective response
Time to overall disease progression
Quality of life as measured by EORTC QLQ.-C30 v3.0 and H&N35 questionnaires

Outline

Not specified

Trial Contact Information

Trial Lead Organizations

Introgen Therapeutics, Incorporated

Julie Sicam, Study coordinator
Ph: 713-797-9960

Trial Sites

U.S.A.

Texas

Houston

Introgen Therapeutics, Incorporated

Julie Sicam
Ph: 713-797-9960

Registry Information

Official Title		A Phase III, Multi-Center, Open-Label, Randomized Study to Compare the Overall Survival and Safety of Bi-Weekly Intratumoral Administration of INGN 201 Versus Weekly Methotrexate in 240 Patients with Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Registered in ClinicalTrials.gov		NCT00041613

Date Submitted to PDQ		2002-04-12

Information Last Verified		2007-01-24

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.