Safety and Efficacy of Radiation/Cetuximab Plus EGFR Antisense DNA for Head and Neck Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT00903461|
Recruitment Status : Terminated (drug supply issues)
First Posted : May 18, 2009
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Squamous Cell of Head and Neck Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma, Head And Neck||Biological: EGFR Antisense DNA||Phase 1|
Subject population We will enroll patients with SCCHN who are suitable for intratumoral injections of EGFR antisense. Please see eligibility criteria.
EGFR AS will be administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as clinically determined . Patients will receive a total of up to 7 weekly intratumoral injections of EGFR antisense (or less if there is no identifiable tumor) starting 2 weeks prior to radiation. Patients will receive standard radiation 70 Gy/200 cGy/daily, 5 days/week,excluding weekends and holidays, with concurrent cetuximab 250 mg/m2, after a loading dose of 400 mg/m2 2 weeks prior to starting radiation.
Statistical Design and Sample Size The study will be conducted in two-stages. In the first stage, 11 patients with stage IVA-C or recurrent disease will be evaluated for safety. If the regimen is deemed safe, a total of 31 patients with stage III or IVA-B, previously untreated SCCHN will be enrolled in the second stage of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Evaluation of Radiation and Cetuximab Plus Intratumoral EGFR Antisense DNA Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma|
|Study Start Date :||April 2012|
|Primary Completion Date :||March 2015|
|Study Completion Date :||August 2016|
Experimental: EGFR Antisense DNA
EGFR AS will be administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as clinically determined. Subjects will receive a total of up to 7 weekly intratumoral injections of EGFR antisense (or less if there is no identifiable tumor) starting 2 weeks prior to radiation. Patients will receive a total EGFR AS dose of 1.92 milligrams in 1.78 milliliters on each weekly treatment. This dose may be delivered equally in the same tumor site per weekly session, the primary tumor or cervical lymph nodes.
Biological: EGFR Antisense DNA
- Disease progression [ Time Frame: baseline, 4, 7, 10, and 13 months after study treatment. ]Change in tumor size based on CT or MRI scans of the same tumor(s) of the head and/or neck as compared to baseline measurement.
- Number of adverse events associated with study treatment [ Time Frame: 2 weeks ]
- Response rate [ Time Frame: baseline, 4, 7, 10, and 13 months after study treatment. ]Change in tumor size based on CT or MRI scans of the same tumor(s) of the head and/or neck as compared to baseline measurement.
- Determine the effect of EGFR antisense therapy on EGFR and EGFR-related biomarkers. [ Time Frame: 3 years ]
- Examine the transfection of the EGFR antisense gene therapy in vivo. [ Time Frame: 3 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903461
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Julie Bauman, MD||University of Pittsburgh|