- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00041613
Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
March 28, 2008 updated by: Introgen Therapeutics
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 Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Introgen Therapeutics, Inc.
- Phone Number: 866.631.4646
- Email: clinicaltrials@introgen.com
Study Contact Backup
- Name: Therapeutics, Inc.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Unversity of Colorado Cancer Center
-
Contact:
- Brittney Hines
- Phone Number: 720-848-0678
- Email: Brittany.Hines@uchsc.edu
-
Principal Investigator:
- Madeleine Kane, MD
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Norton Healthcare Pavilion
-
Contact:
- Daniela Neamtu
- Phone Number: 502-629-4679
- Email: daniela.neamtu@nortonhealthcare.org
-
-
Maryland
-
Baltimore, Maryland, United States, 21204
- Recruiting
- Cancer Center of GBMC
-
Contact:
- Lauren Titus
- Phone Number: 443-849-3285
- Email: ltitus@gbmc.org
-
Principal Investigator:
- Marshall Levine, MD
-
-
South Carolina
-
Columbia, South Carolina, United States, 29209
- Recruiting
- WJB Dorn VA Medical Center
-
Contact:
- Justin Reynolds
- Phone Number: 6074 803-776-4000
- Email: justin.reynolds@va.gov
-
Principal Investigator:
- William Hrushesky, MD
-
-
Texas
-
Dallas, Texas, United States, 75201
- Recruiting
- Mary Crowley Medical Research Center
-
Contact:
- Arlen Waclawczyk
- Phone Number: 214-658-1985
- Email: awaclawczyk@mcmrc.com
-
Principal Investigator:
- John Nemunaitis, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 18 years or older
- Not eligible for surgery
- Must have had radiation and chemotherapy treatments
- No prior methotrexate treatments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kerstin Menander, MD
- Study Chair: Julie L Sicam, MT (ASCP) MSHS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 11, 2002
First Submitted That Met QC Criteria
July 11, 2002
First Posted (Estimate)
July 12, 2002
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 28, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Squamous Cell
-
National Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage... and other conditionsCanada, United States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Emory UniversitySynta Pharmaceuticals Corp.TerminatedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage I Hypopharyngeal Squamous Cell Carcinoma | Stage I Laryngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II... and other conditionsUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell... and other conditionsUnited States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingAdvanced Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of Unknown Primary | Advanced Hypopharyngeal Squamous Cell Carcinoma | Advanced Laryngeal Squamous Cell Carcinoma | Advanced Oropharyngeal Squamous Cell CarcinomaUnited States, Canada
-
City of Hope Medical CenterNational Cancer Institute (NCI); Genentech, Inc.RecruitingLocally Advanced Skin Squamous Cell Carcinoma | Unresectable Skin Squamous Cell Carcinoma | Resectable Skin Squamous Cell CarcinomaUnited States
-
Baptist Health South FloridaRegeneron PharmaceuticalsWithdrawnSquamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Advanced Squamous Cell CarcinomaUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteAstraZeneca; Brooklyn ImmunoTherapeutics, LLCActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Oropharynx Squamous Cell Carcinoma | Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma | Hypopharynx Squamous Cell Carcinoma | Paranasal Sinus Squamous Cell Carcinoma | Larynx Squamous Cell CarcinomaUnited States
-
UNC Lineberger Comprehensive Cancer CenterMayo Clinic; National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCarcinoma, Squamous Cell | Head and Neck Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | Oropharynx Squamous Cell CarcinomaUnited States
Clinical Trials on INGN 201
-
Introgen TherapeuticsUnknownCarcinoma, Squamous CellUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Department of Health and Human ServicesTerminated
-
National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
Introgen TherapeuticsCompletedLocally Advanced Breast Cancer (LABC)United States
-
National Cancer Institute (NCI)CompletedLip and Oral Cavity Cancer | Oropharyngeal Cancer | Tongue Cancer | Stage 0 Lip and Oral Cavity Cancer | Stage 0 Oropharyngeal CancerUnited States
-
Southwest Oncology GroupNational Cancer Institute (NCI)TerminatedHead and Neck CancerUnited States
-
Introgen TherapeuticsM.D. Anderson Cancer CenterUnknownNeoplasm Metastasis | Malignant MelanomaUnited States
-
QurAlis CorporationRecruitingAmyotrophic Lateral SclerosisCanada, Germany, Netherlands, Ireland, United Kingdom, Belgium
-
Modulation Therapeutics, Inc.H. Lee Moffitt Cancer Center and Research InstituteRecruitingUveal Melanoma | MetastaticUnited States
-
Royal Prince Alfred Hospital, Sydney, AustraliaCompleted