Carcinoma, Squamous CellPhase 1NCT02438995
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study testing Intraarterial Cetxuimab (Erbitux) in people with Carcinoma, Squamous Cell and Carcinoma, Squamous Cell of Head and Neck, run by Northwell Health at 1 site in United States.
Trial summary
This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell, Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- Intraarterial Cetxuimab (Erbitux)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female patients of ≥18 years of age.
- Patients with a documented diagnosis of recurrent head and neck squamous cell cancer (squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic carcinoma).
- Patients must have at least one confirmed and evaluable tumor site. The recurrence must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A confirmed recurrence site may also be biopsy-proven
- Tumor Recurrence which is surgically unresectable
- Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥ three months.
- Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
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- Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.
- Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
- Patients who refuse surgery.
Who cannot join
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
- Pre-existing cardiac or respiratory disorders
- Unrelated malignancy within 3 years
- History of hypersensitivity reactions to other EGFR inhibitors
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- Metastatic disease
- Less than 6 months from prior Radiation Therapy (Arm 1)
- Previous exposure to Cetuximab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).
- Being tested
- Intraarterial Cetxuimab (Erbitux)
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarterial Cetxuimab (Erbitux)Drug
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab with Radiation Therapy | Experimental | For subjects receiving radiation therapy, the treatment schedule will consist of a re-irradiation dose of approximately 70 Gy over 6-7 weeks. This experimental treatment arm will add IA Cetuximab administration every three weeks up to 2 doses to this radiation schedule. Receives: Drug: Intraarterial Cetxuimab (Erbitux) |
| Cetuximab Alone | Experimental | For subjects who are not candidates for re-irradiation, this experimental treatment arm will include only IA Cetuximab administration every three weeks up to 2 doses. Receives: Drug: Intraarterial Cetxuimab (Erbitux) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab.
Measured: 30 days
Descriptive frequency of subjects experiencing toxicities.
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 posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health
- Investigators
- John Boockvar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438995
- Sponsor's protocol ID
- 15-182
- Status last verified
- Oct 2021
- First submitted
- 6 May 2015
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Tham T, White TG, Chakraborty S, Lall RR, Ortiz R, Langer DJ, Shatzkes D, Filippi CG, Kraus D, Boockvar JA, Costantino PD. Intra-arterial cetuximab for the treatment of recurrent unresectable head and neck squamous cell carcinomadagger. J Exp Ther Oncol. 2016 Nov;11(4):293-301.
PubMed 27849340
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02438995
- Acronym / sponsor ID
- 15-182
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab with Radiation Therapy | Experimental | Drug: Intraarterial Cetxuimab (Erbitux)For subjects receiving radiation therapy, the treatment schedule will consist of a re-irradiation dose of approximately 70 Gy over 6-7 weeks. This experimental treatment arm will add IA Cetuximab administration every three weeks up to 2 doses to this radiation schedule. |
| Cetuximab Alone | Experimental | Drug: Intraarterial Cetxuimab (Erbitux)For subjects who are not candidates for re-irradiation, this experimental treatment arm will include only IA Cetuximab administration every three weeks up to 2 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients of ≥18 years of age.
- Patients with a documented diagnosis of recurrent head and neck squamous cell cancer (squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic carcinoma).
- Patients must have at least one confirmed and evaluable tumor site. The recurrence must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A confirmed recurrence site may also be biopsy-proven
- Tumor Recurrence which is surgically unresectable
- Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥ three months.
Key exclusion criteria (9 listed)
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
- Pre-existing cardiac or respiratory disorders
- Unrelated malignancy within 3 years
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 |
|---|---|---|
| Intraarterial Cetxuimab (Erbitux)Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) | Drug | Cetuximab Alone, Cetuximab with Radiation Therapy |
Primary outcome
The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab.
Time frame: 30 days
Descriptive frequency of subjects experiencing toxicities.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Derived from this study: PubMed 27849340Tham T, White TG, Chakraborty S, Lall RR, Ortiz R, Langer DJ, Shatzkes D, Filippi CG, Kraus D, Boockvar JA, Costantino PD. Intra-arterial cetuximab for the treatment of recurrent unresectable head and neck squamous cell carcinomadagger. J Exp Ther Oncol. 2016 Nov;11(4):293-301.
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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.
John Boockvar, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intraarterial Cetxuimab (Erbitux) in people with Carcinoma, Squamous Cell and Carcinoma, Squamous Cell of Head and Neck, run by Northwell Health at 1 site 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab. (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT02438995, which also lists 1 linked publication.
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 3 Nov 2021.