Carcinoma, Squamous CellPhase 3NCT00041613
Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
A Phase 3 study testing INGN 201 in people with Carcinoma, Squamous Cell, run by Introgen Therapeutics at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- INGN 201
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 18 years or older
- Not eligible for surgery
- Must have had radiation and chemotherapy treatments
- No prior methotrexate treatments
Trial locations and contacts
5 sites in 1 country.
Therapeutics, Inc. contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Unversity of Colorado Cancer Center
Aurora, Colorado, 80045
Brittney Hines, 720-848-0678, Brittany.Hines@uchsc.edu
Madeleine Kane, MD
- Recruiting
Cancer Center of GBMC
Baltimore, Maryland, 21204
Lauren Titus, 443-849-3285, ltitus@gbmc.org
Marshall Levine, MD
- Recruiting
WJB Dorn VA Medical Center
Columbia, South Carolina, 29209
Justin Reynolds, 803-776-4000 ext. 6074, justin.reynolds@va.gov
William Hrushesky, MD
- Recruiting
Mary Crowley Medical Research Center
Dallas, Texas, 75201
Arlen Waclawczyk, 214-658-1985, awaclawczyk@mcmrc.com
John Nemunaitis, MD
- Recruiting
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
Daniela Neamtu, 502-629-4679, daniela.neamtu@nortonhealthcare.org
John Hamm, MD
About this study
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.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- INGN 201
- Keywords
- Refractory Squamous Cell Carcinoma of the Head and Neck
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INGN 201Genetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Introgen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kerstin Menander, MD, Study directorJulie L Sicam, MT (ASCP) MSHS, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041613
- Sponsor's protocol ID
- T301
- Status last verified
- Mar 2008
- First submitted
- 11 Jul 2002
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
- ClinicalTrials.gov ID
- NCT00041613
- Acronym / sponsor ID
- T301
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Refractory Squamous Cell Carcinoma of the Head and Neck
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Introgen TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 12 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INGN 201 | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therapeutics, Inc. contact
Kerstin Menander, MD study director
Julie L Sicam, MT (ASCP) MSHS study chair
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INGN 201 in people with Carcinoma, Squamous Cell, run by Introgen Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Introgen Therapeutics, Inc. (866.631.4646, clinicaltrials@introgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.