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Chemotherapy

INGN 201 + Chemotherapy for Squamous Cell Carcinoma

Phase 3

Waitlist Available

Research Sponsored by Introgen Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be 18 years or older

Eligible for chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will compare the effects of a modified virus that transfers the p53 gene to tumor cells, in combination with chemotherapy, to chemotherapy alone in patients with recurrent SCCHN.

Who is the study for?

This trial is for adults with recurrent squamous cell cancer of the head and neck who have already undergone radiation treatment but are not candidates for surgery. Participants must be eligible to receive chemotherapy.Check my eligibility

What is being tested?

The study tests a gene therapy called INGN 201, which introduces a normal p53 gene into tumor cells, combined with standard chemotherapy (cisplatin and fluorouracil), against the same chemotherapy alone in patients whose cancer persisted after surgery and radiotherapy.See study design

What are the potential side effects?

Potential side effects may include typical reactions to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood counts, as well as possible specific reactions related to the gene therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am cleared to receive chemotherapy.

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I have undergone radiation treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Introgen TherapeuticsLead Sponsor

4 Previous Clinical Trials

85 Total Patients Enrolled

Kerstin Menander, MDStudy Director

1 Previous Clinical Trials

Julie L Sicam, MT (ASCP) MSHSStudy Chair

1 Previous Clinical Trials

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00041626 — Phase 3

Squamous Cell Carcinoma Research Study Groups:

Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00041626 — Phase 3

Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00041626 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple areas in which this research is being conducted?

"There are 8 available for this study including University of Arkansas in Little Rock, Unversity of Colorado Cancer Center in Aurora, and Mary Crowley Medical Research Center in Dallas. The other 5 sites are located elsewhere."

Answered by AI

Has this medication been federally sanctioned?

"There is some data to support the efficacy of this treatment and it has undergone multiple rounds of testing, so we believe it to be safe and give it a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00041626.

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