A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer (BMX-HN)
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|ClinicalTrials.gov Identifier: NCT02990468|
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: BMX-001 Radiation: Radiation Therapy Drug: Cisplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 / Phase 2 Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer|
|Actual Study Start Date :||April 19, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: Radiation Therapy, Cisplatin and BMX-001
In Phase 1, safety and tolerability of BMX-001 will be assessed using a Continual Reassessment Method and a maximum tolerated dose (MTD) will be determined using a single arm design. In Phase 2, the severity of radiation-induced mucositis and xerostomia will be assessed using a single arm design.
Radiation: Radiation Therapy
Patients will receive standard dose intensity modulated radiation therapy (IMRT).
Cisplatin will be administered per institution's standard of care practice.
- Assess the safety of the study drug by calculating the proportion of patients who experience a grade 4 or study drug related adverse events, as assessed by CTCAE v 4.03. [ Time Frame: 1 year ]This outcome is to confirm the safety and tolerability of the MTD of BMX-001 in conjunction with RT and concurrent cisplatin in a cohort of newly diagnosed patients with locally advanced head and neck cancers.
- Reduction of radiation-induced mucositis [ Time Frame: 1 year ]Mucositis will be scored using the CTCAE version 4.03 and evaluation will also be done using the Functional Assessment of Cancer Therapy for Head and Neck (FACT-HN) to be administered on screening and post therapy.
- Reduction of radiation-induced mucositis [ Time Frame: 1 year ]Mucositis will be scored using the CTCAE version 4.03 and evaluation will also be done using the Oral Mucositis Weekly Questionnaire-Head+Neck (OMWQ-HN) to be administered on screening and post therapy.
- Reduction of radiation-induced xerostomia [ Time Frame: 1 year ]Xerostomia will be assessed using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
- Reduction of radiation-induced xerostomia [ Time Frame: 1 year ]Xerostomia will be assessed using the Xerostomia-Related Quality of Life Scale (XeQoLS).
- Reduction of radiation-induced xerostomia [ Time Frame: 1 year ]Xerostomia will also be assessed by measurement of both unstimulated and stimulated saliva production at baseline, at the end of radiation therapy, and at 6 and 12 months post radiation therapy.
- Reduction of radiation dermatitis [ Time Frame: 1 year ]Radiation dermatitis will be assessed by the proportion of patients affected using the CTCAE version 4.03.
- Reduction of radiation dermatitis [ Time Frame: 1 year ]Effect of radiation dermatitis will also be assessed by analyzing the change in the Dermatology Life Quality Index (DLQI) measurement which is obtained at baseline, at the end of radiation therapy, and at 6 and 12 months post radiation therapy. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
- Assess the efficacy of the MTD of BMX-001 based upon overall survival. [ Time Frame: 1 year ]
- Assess the efficacy of the MTD of BMX-001 based upon median progression-free survival. [ Time Frame: 1 year ]
- Assess radiographic response in patients treated with the MTD of BMX-001. [ Time Frame: 1 year ]Assessment of measurable disease by imaging is completed at baseline and post-completion of the study treatment (at 3 and 12 month follow up). Imaging reads will be done per the institutional standard of practice.
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): NCT02990468
|Contact: Sara Penchevfirstname.lastname@example.org|
|Contact: James D Crapo, MDemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Amy Filler-Katz 402-552-2790 firstname.lastname@example.org|
|Principal Investigator: Weining Zhen, MD|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Joan Cahill, RN 919-668-5211 email@example.com|