Head and Neck CancerPhase 1/2BMX-HNNCT02990468
A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer
A Phase 1/2 study testing BMX-001, Radiation Therapy and Cisplatin in people with Head and Neck Cancer, run by BioMimetix JV, LLC at 4 sites in United States.
Trial summary
This is a Phase 1 / Phase 2 study of newly diagnosed patients with biopsy-proven head and neck cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment with cisplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- BMX-001, Radiation Therapy and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Apr 2017to 31 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, or oral cavity with clinical or pathologic high-risk features for whom cisplatin and radiation would be considered appropriate care.
- Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.1 Gy with a cumulative radiation dose between 60 Gy and 70 Gy depending on whether patients are considered post-operative high risk or unresectable/organ preservation high risk. Planned radiation treatment fields must include at least two oral sites buccal mucosa, retromolar trigone, floor of mouth, oral tongue, soft palate, hard palate) with a portion of each site receiving a minimum total of 50 Gy.
- Patients who are to undergo definitive chemoradiation must have clinically or radiographically evident measurable disease at the primary site and/or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted.
- Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck that are positive for squamous cell carcinoma are sufficient for diagnosis pending pathology review at participating institutions.
- For patients undergoing curative intent resection the following criteria are required:
- Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma
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- Patients must have undergone gross total surgical resection within 42 days prior to registration and beginning of therapy under the clinical trial. Note: Patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection.
- Clinical or pathologic stage Stage III-IVb per the American Joint Committee on Cancer (AJCC), 7th edition.
- General history and physical examination by a radiation oncologist and medical oncologist within 4 weeks prior to enrollment.
- Examination by an ear/nose/throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to enrollment.
- Zubrod Performance Status 0-2 within 4 weeks prior to enrollment
- Complete blood count (CBC)/differential obtained within 7 days prior to starting the study drug with adequate bone marrow function, defined as follows:
- Hemoglobin ≥ 9.0 g/dl;
- Platelets ≥ 100,000 cells/mm3;
- Absolute neutrophil count (ANC) > 1,500 cell/mm3.
- Adequate hepatic function as defined as follows:
- Total bilirubin < 2x institutional upper limit of normal (ULN) within 7 days prior to starting the study drug;
- Aspartate aminotransferase (AST) and AST <3x institutional ULN within 7 days prior to starting the study drug.
- Adequate renal function defined as follows:
- Serum creatinine < 1.5 mg/dl within 7 days prior to starting the study drug or creatinine clearance rate (CCr) ≥ 50 mL/min within 7 days prior to starting the study drug determined by 24-hour collection or estimated by Cockcroft-Gault formula:
- CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
- Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001.
- Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment.
Who cannot join
- Stage I or II; T1N1 and T2N1 stage III presentations per AJCC 7th edition
- Distant metastasis
- Hypertension requiring 3 or more anti-hypertensive medications to control
- Grade ≥2 hypotension at screening
- Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
- History of syncope within the last 6 months
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- Patients receiving, or unable to stop use at least 1 week prior to receiving the first dose of BMX-001, medications listed in Section 12.2 of the protocol are not eligible.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
- Women who are breast feeding are not eligible
- Prior allergic reaction to cisplatin
- Known hypersensitivity to compounds of similar chemical composition to BMX-001
- Grade 3-4 electrolyte abnormalities (CTCAE v 4.03) except sodium, which must be ≥126 mmol/L.
- Prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell carcinoma of the skin, resected T1-2N0M0 differentiated thyroid cancers, invasive cancers with a 3-year disease-free interval, Ta bladder cancers, or low and favorable intermediate risk prostate cancer.
- Prior history of HNSCC receiving radiation or chemo-radiation.
- Prior systemic chemotherapy for the study cancer (including neoadjuvant chemotherapy); note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer.
- Severe, active co-morbidity, defined as follows:
- Cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents or myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment;
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment;
- History or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication;
- Acute bacterial or fungal infection requiring intravenous antibiotics within 7 days of enrollment;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
- Patients known to be HIV positive or have active viral hepatitis.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida- Gainesville
Gainesville, Florida, 32609
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase 1 / Phase 2 Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer
This is a Phase 1 / Phase 2 study of newly diagnosed patients with biopsy-proven head and neck cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment with cisplatin. BMX-001 added to radiation therapy and cisplatin is expected to reduce radiation-induced mucositis and xerostomia and also has the potential to benefit the survival of head and neck cancer patients. In Phase 1, safety and tolerability of BMX-001 will be assessed using a Continual Reassessment Method (CRM) and a maximum tolerated dose (MTD) will be determined. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2 both safety and efficacy of BMX-001 will be evaluated. Impact on mucositis and xerostomia will also be assessed. A maximum of 48 patients will be enrolled to the MTD dose determined in Phase 1 to confirm the MTD. The investigators hypothesize that BMX-001 when added to standard radiation therapy and cisplatin will be safe at pharmacologically relevant doses in patients with newly diagnosed head and neck cancer. The investigators also hypothesize that in Phase 2 of this study the addition of BMX-001 will reduce the severity of radiation-induced mucositis and xerostomia in patients receiving head and neck radiation therapy.
- Conditions
- Head and Neck Cancer
- Being tested
- BMX-001, Radiation Therapy, Cisplatin
- Keywords
- Mucositis, Xerostomia
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMX-001Drug
Subcutaneous injection.
Radiation TherapyRadiation
Patients will receive standard dose intensity modulated radiation therapy (IMRT).
CisplatinDrug
Cisplatin will be administered per institution's standard of care practice.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy, Cisplatin and BMX-001 | Experimental | 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. Receives: Drug: BMX-001; Radiation: Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Safety of the Study Drug by Calculating the Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events, as Assessed by CTCAE v 4.03.
This outcome is to confirm the safety and tolerability of escalating doses of BMX-001 in conjunction with RT and concurrent cisplatin in a cohort of newly diagnosed patients with locally advanced head and neck cancers. Each dose will be reported separately.
Measured: 1 year
Incidence Radiation-induced Mucositis by Clinician Scoring
Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Higher scores are indicative of worse symptoms. Grade 0-5. We are reporting the incidence of the patients that had mucositis grade 1-5.
Measured: 6 months
Secondary outcomes (5)
Incidence of Radiation-induced Xerostomia by Stimulated Saliva Production
Xerostomia will also be assessed by measurement of stimulated saliva production posttreatment.
Measured: 6 months
Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production
Xerostomia will also be assessed by measurement of unstimulated saliva production post treatment.
Measured: 6 months
Incidence of Radiation-induced Xerostomia by Clinician Scoring
Xerostomia will be assessed using Maximum Xerostomia Clinical Score Common Terminology Criteria for Adverse Events (CTCAE) 4.03. Scores range from 0 to 5 with 0 being no xerostomia and 5 being the worst. Mean maximum xerostomia grade of patients assessed is reported.
Measured: 6 months
Duration of Radiation-induced Mucositis
Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Duration of Oral Mucositis WHO Grade 3 or higher measured as the days of severe oral mucositis.
Measured: 6 month 6 months
To Examine the Impact on Radiation Dermatitis When Adding BMX-001 to Treatment
To examine the impact on radiation dermatitis of BMX-001 in combination with RT and concurrent cisplatin at 30-39 Gy, 40-49 Gy, 50-59 Gy, and 60-70 Gy, the duration of radiation dermatitis, and evaluation of radiation dermatitis-related patient-reported outcomes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start19 Apr 2017
- Primary completion21 Feb 2020
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMimetix JV, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990468
- Sponsor's protocol ID
- BMX-HN-001
- Acronym
- BMX-HN
- Status last verified
- Feb 2023
- First submitted
- 28 Nov 2016
- Last updated
- 15 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 / Phase 2 Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02990468
- Acronym / sponsor ID
- BMX-HN / BMX-HN-001
- Conditions
- Head and Neck Cancer
- Keywords
- Mucositis, Xerostomia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- BioMimetix JV, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, University of California, San Francisco
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 / Phase 2 study of newly diagnosed patients with biopsy-proven head and neck cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment with cisplatin. BMX-001 added to radiation therapy and cisplatin is expected to reduce radiation-induced mucositis and xerostomia and also has the potential to benefit the survival of head and neck cancer patients. In Phase 1, safety and tolerability of BMX-001 will be assessed using a Continual Reassessment Method (CRM) and a maximum tolerated dose (MTD) will be determined. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2 both safety and efficacy of BMX-001 will be evaluated. Impact on mucositis and xerostomia will also be assessed. A maximum of 48 patients will be enrolled to the MTD dose determined in Phase 1 to confirm the MTD. The investigators hypothesize that BMX-001 when added to standard radiation therapy and cisplatin will be safe at pharmacologically relevant doses in patients with newly diagnosed head and neck cancer. The investigators also hypothesize that in Phase 2 of this study the addition of BMX-001 will reduce the severity of radiation-induced mucositis and xerostomia in patients receiving head and neck radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy, Cisplatin and BMX-001 | Experimental | Drug: BMX-001, Radiation: Radiation Therapy, Drug: CisplatinIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, or oral cavity with clinical or pathologic high-risk features for whom cisplatin and radiation would be considered appropriate care.
- Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.1 Gy with a cumulative radiation dose between 60 Gy and 70 Gy depending on whether patients are considered post-operative high risk or unresectable/organ preservation high risk. Planned radiation treatment fields must include at least two oral sites buccal mucosa, retromolar trigone, floor of mouth, oral tongue, soft palate, hard palate) with a portion of each site receiving a minimum total of 50 Gy.
- Patients who are to undergo definitive chemoradiation must have clinically or radiographically evident measurable disease at the primary site and/or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted.
- Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck that are positive for squamous cell carcinoma are sufficient for diagnosis pending pathology review at participating institutions.
- For patients undergoing curative intent resection the following criteria are required:
Key exclusion criteria (23 listed)
- Stage I or II; T1N1 and T2N1 stage III presentations per AJCC 7th edition
- Distant metastasis
- Hypertension requiring 3 or more anti-hypertensive medications to control
- Grade ≥2 hypotension at screening
- Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMX-001Subcutaneous injection. | Drug | Radiation Therapy, Cisplatin and BMX-001 |
| Radiation TherapyPatients will receive standard dose intensity modulated radiation therapy (IMRT). | Radiation | Radiation Therapy, Cisplatin and BMX-001 |
| CisplatinCisplatin will be administered per institution's standard of care practice. | Drug | Radiation Therapy, Cisplatin and BMX-001 |
Primary outcome
Assess the Safety of the Study Drug by Calculating the Proportion of Patients Who Experience Grade 4 or 5 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 escalating doses of BMX-001 in conjunction with RT and concurrent cisplatin in a cohort of newly diagnosed patients with locally advanced head and neck cancers. Each dose will be reported separately.
Incidence Radiation-induced Mucositis by Clinician Scoring
Time frame: 6 months
Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Higher scores are indicative of worse symptoms. Grade 0-5. We are reporting the incidence of the patients that had mucositis grade 1-5.
5 secondary outcomes
Incidence of Radiation-induced Xerostomia by Stimulated Saliva Production
Time frame: 6 months
Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production
Time frame: 6 months
Incidence of Radiation-induced Xerostomia by Clinician Scoring
Time frame: 6 months
Duration of Radiation-induced Mucositis
Time frame: 6 month 6 months
To Examine the Impact on Radiation Dermatitis When Adding BMX-001 to Treatment
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMX-001, Radiation Therapy and Cisplatin in people with Head and Neck Cancer, run by BioMimetix JV, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Safety of the Study Drug by Calculating the Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events, as Assessed by CTCAE v 4.03. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.