Recurrent Adenoid Cystic Carcinoma of the Oral CavityPhase 1NCT00470496
Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
A Phase 1 study testing HPPH, photodynamic therapy and conventional surgery in people with Recurrent Adenoid Cystic Carcinoma of the Oral Cavity and Recurrent Basal Cell Carcinoma of the Lip, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- What is being tested?
- HPPH, photodynamic therapy and conventional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2006to 30 Aug 2018
- 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
- Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
- Female patients must not be pregnant (documented by human chorionic gonadotropin [HCG] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
- No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT
Who cannot join
- Patients with unresectable tumors
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- White blood cell (WBC) < 4,000
- Platelet count < 100,000
- Prothrombin time 1.5 times above the upper normal limit
- Total serum bilirubin > 2.0 mg/d
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- Serum creatinine > 2 mg%
- Alkaline phosphatase (hepatic) > 3 times the upper normal limit
- Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- Patients on concurrent chemotherapy or radiation therapy will be excluded
- Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days
- Has not recovered from toxicity of prior therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.
SECONDARY OBJECTIVES:
- To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.
II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.
III. Observe for wound complications.
OUTLINE: This is a dose-escalation study of laser light.
Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.
- Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx
- Being tested
- HPPH, photodynamic therapy, conventional surgery
- Medical subject headings
- Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck, Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPHDrug
Also called Photochlor
Given IV
photodynamic therapyDrug
Also called Light Infusion Therapy™, PDT, therapy, photodynamic
Undergo laser light exposure
conventional surgeryProcedure or surgery
Also called surgery, conventional
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (intraoperative PDT) | Experimental | Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2. Receives: Drug: HPPH; Drug: photodynamic therapy; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
Measured: 30 days
Secondary outcomes (2)
Time to tumor progression or recurrence
Measured: From baseline until objective tumor progression, assessed up to 5 years
Uptake and distribution of HPPH in resected tumor tissue
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study start19 Oct 2006
- Primary completion28 Oct 2011
- Study completion30 Aug 2018
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 Recurrent Adenoid Cystic Carcinoma of the Oral CavityStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Arshad, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470496
- Sponsor's protocol ID
- I 74606
- Other IDs
- NCI-2010-01941, I 74606
- Status last verified
- Jul 2022
- First submitted
- 3 May 2007
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rigual NR, Shafirstein G, Frustino J, Seshadri M, Cooper M, Wilding G, Sullivan MA, Henderson B. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387.
PubMed 23868427
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00470496
- Acronym / sponsor ID
- I 74606
- Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 19 Oct 2006 (actual)
- Primary completion
- 28 Oct 2011 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 7 May 2007 (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 phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
Detailed description
PRIMARY OBJECTIVES:
- Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.
SECONDARY OBJECTIVES:
- To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.
II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.
III. Observe for wound complications.
OUTLINE: This is a dose-escalation study of laser light.
Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (intraoperative PDT) | Experimental | Drug: HPPH, Drug: photodynamic therapy, Procedure: conventional surgeryPatients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
- Female patients must not be pregnant (documented by human chorionic gonadotropin [HCG] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
- No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT
Key exclusion criteria (12 listed)
- Patients with unresectable tumors
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- White blood cell (WBC) < 4,000
- Platelet count < 100,000
- Prothrombin time 1.5 times above the upper normal limit
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 |
|---|---|---|
| HPPHAlso: PhotochlorGiven IV | Drug | Treatment (intraoperative PDT) |
| photodynamic therapyAlso: Light Infusion Therapy™, PDT, therapy, photodynamicUndergo laser light exposure | Drug | Treatment (intraoperative PDT) |
| conventional surgeryAlso: surgery, conventionalUndergo surgery | Procedure or surgery | Treatment (intraoperative PDT) |
Primary outcome
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
Time frame: 30 days
2 secondary outcomes
Time to tumor progression or recurrence
Time frame: From baseline until objective tumor progression, assessed up to 5 years
Uptake and distribution of HPPH in resected tumor tissue
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 23868427Rigual NR, Shafirstein G, Frustino J, Seshadri M, Cooper M, Wilding G, Sullivan MA, Henderson B. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387.
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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.
Hassan Arshad principal investigator
Roswell Park Cancer Institute
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 HPPH, photodynamic therapy and conventional surgery in people with Recurrent Adenoid Cystic Carcinoma of the Oral Cavity and Recurrent Basal Cell Carcinoma of the Lip, run by Roswell Park Cancer Institute 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 5 inclusion and 12 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 25 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity (time frame: 30 days). 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 NCT00470496, 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 25 Jul 2022.