Status:
COMPLETED
Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Mouth Neoplasms
Head and Neck Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Advanced-stage head and neck cancer (head and neck squamous cell carcinoma \[HNSCC\]) has moderately successful treatment outcomes, usually involving surgery as part of the standard tr...
Detailed Description
BACKGROUND: * The five-year survival rate for head and neck squamous cell carcinoma (HNSCC) has remained at approximately 50% for more than three decades. * In HNSCC, the AKT-mTOR-pS6 pathway is aber...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- Males and females and members of any race or ethnic group who meet the eligibility criteria may participate in this trial.
- INCLUSION CRITERIA:
- Participants must meet all of the following inclusion criteria:
- Age 18 years and older
- Histologically confirmed previously untreated squamous cell carcinoma o f the oral cavity or oropharynx accessible for biopsy
- Clinical stage II, III, or IVA disease without distant metastasis, as defined by the American Joint Committee on Cancer Staging System, Seventh edition.
- Definitive therapy to include surgical resection or chemoradiation for curative purposes
- Life expectancy o f greater than 6 months
- Eastern Cooperative Oncology Group ( ECOG) performance status of 0 or 1
- Willing and able to provide written informed consent
- EXCLUSION CRITERIA:
- Participants who meet any of the following criteria are not eligible for enrollment:
- Surgical resection or chemoradiation of the HNSCC is contraindicated
- Prior head or neck squamous cell carcinoma within 5 years, except for previously treated skin cancer
- Received chemotherapy targeted monoclonal antibody therapy or investigational therapy within 30 days prior to enrollment
- Previous radiation therapy to the head or neck
- No measurable tumor remaining after prior biopsy or negative margins from prior biopsy
- Inadequate hematologic, renal or liver function within l4 days prior to the first rapamycin dosing visit, as defined by:
- Absolute neutrophil count less than 1.5 times 10 (9)/L
- CD4 count \< 400 (to account for natural fluctuations in CD4 levels, participants with at least one CD4 count (Bullet) 400 within 14 days prior to dosing will not be excluded)
- Platelet count less than 100 times 10(9)/L
- Hemoglobin less than l0 g/dL (eligibility level for hemoglobin may be reached by transfusion)
- AST, ALT or bilirubin greater than 1.5 times the upper limit of local lab normal values
- Total cholesterol level greater than 350 mg/dL
- Triglyceride level greater than 400 mg/dL
- International Normalized Ratio (INR) greater than 1.5
- Serum creatinine greater than 1.5mg/dL
- Active hepatitis or HBV or HCV infection
- Women who are pregnant or lactating (female of child-bearing age must be abstinent or use a barrier type birth control method throughout the study)
- Presence of any contraindications to rapamycin therapy, including HlV-protease inhibitors and drugs or agents that are modulators of cytochrome P-450 3A4 (CYP3A4) and p-glycoprotein(P-gp)
- Hypersensitivity to rapamycin
- 11 .Has received live vaccine (such as influenza nasal vaccine measles mumps, rubella, oral polio, B CG, yellow fever, varicella, or TY2la typhoid) in the past 30 days or has plans to take a live vaccine in the next 3 months
- 12\. Any cognitive impairment that limits the subject s or the subject s legally authorized representative s ability to understand the protocol, provide informed consent or assent, or to comply with the protocol procedures
- Unable or unwilling to comply with the requirements of the protocol
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01195922
Start Date
August 1 2010
End Date
December 1 2015
Last Update
December 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892