- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00195299
Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck
December 18, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck
This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to beginning their standard therapy for their specific disease.
The primary objective of this study is to identify biomarkers of temsirolimus activity.
Study Overview
Study Type
Observational
Enrollment
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Louisiana
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Shreveport, Louisiana, United States, 71130
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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
Inclusion Criteria:
- Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma of the oral cavity, oral pharynx, hypopharynx or larynx.
- Subjects willing to undergo tumor biopsies.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Age >/= 18 years.
Exclusion Criteria:
- Subjects receiving anticoagulation therapy.
- Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia.
- Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or investigational agent for their head and neck cancer.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Major Dates
Study Start
April 1, 2005
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
December 27, 2007
Last Update Submitted That Met QC Criteria
December 18, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- 3066K1-147
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 Squamous Cell Carcinoma
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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
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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
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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
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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
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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
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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
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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
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Baptist Health South FloridaRegeneron PharmaceuticalsWithdrawnSquamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Advanced Squamous Cell CarcinomaUnited States
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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
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Hyunseok Kang, MDNeoImmuneTechRecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Resectable Oropharyngeal Squamous Cell CarcinomaUnited States
Clinical Trials on Temsirolimus
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Sheba Medical CenterStanley Medical Research InstituteUnknownSchizophrenia | Schizoaffective DisorderIsrael
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St. Joseph's Healthcare HamiltonPfizer; McMaster UniversityCompletedRenal Cell CarcinomaCanada
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AVEO Pharmaceuticals, Inc.Completed
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Children's Hospital Medical Center, CincinnatiWithdrawnLymphoma, B-Cell | Leukemia, B-cellUnited States
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Dana-Farber Cancer InstituteWyeth is now a wholly owned subsidiary of Pfizer; Millennium Pharmaceuticals...CompletedMultiple MyelomaUnited States
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Mathias Witzens-HarigCharite University, Berlin, Germany; Ludwig-Maximilians - University of Munich and other collaboratorsUnknownDiffuse Large B-Cell LymphomaGermany
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Georgetown UniversityWyeth is now a wholly owned subsidiary of PfizerCompletedAdvanced Solid TumorsUnited States
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Goethe UniversityCompletedAcute Myeloblastic LeukemiaGermany
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Wyeth is now a wholly owned subsidiary of PfizerPfizerCompletedBreast Neoplasms
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Loyola UniversityWyeth is now a wholly owned subsidiary of PfizerTerminated