Skin CancerPhase 1NCT01043016
Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
A Phase 1 study testing Photodynamic therapy in people with Skin Cancer and Esophageal Cancer, run by Fujian Longhua Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
The purpose of this study is to determine the safety and maximum tolerated dose of Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer and esophageal cancer). Projected accrual: A total of 18-24 patients will be accrued for this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Skin Cancer, Esophageal Cancer
- What is being tested?
- Photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Apr 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years old (patient over 60 years old must not have three kinds of complications of heart, lung, liver and kidney function at the same time), no gender limited;
- Advanced malignant solid tumors confirmed by histology or cytology ( skin cancer and esophageal cancer), malignant tumor can be illuminated directly (or via endoscopy) by the laser fiber;
- Recurrence after surgery, radiotherapy,chemoradiotherapy; or have financial difficulties, give up any other treatment;
- Patients received chemotherapy, biological therapy or other research drugs must exceed at least 4 weeks or more than five half-life;
- Life expectancy: > 3 months;
- Can collaboratively observe the adverse events and efficacy;
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- No other anti-tumor treatment (including steroids);
- Patients or their legal representative can sign the informed consent;
- Performance status: ECOG ≤ 2,
Who cannot join
- No pathological evidence;
- Have allergic effect to this drug;
- HIV antibody positive, or suffering from other acquired and congenital immune deficiency diseases, or have organ transplant history;
- Neutrophil count < 1.5 × 109 / L, platelet < 100 × 109 / L, or hemoglobin < 90 g /L;
- Serum Cr above 1.5 times of normal reference range or Cr clearance rate < 50 ml/min;
- ALT, or AST > 2.5 times of the normal range when no hepatic metastasis occur; or ALT, or AST > 5 times of the normal range when hepatic metastasis exist;
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- Serum bilirubin > 1.5 times of the normal range;
- Fever above 38 ℃, or have active infection which can affect the clinical trials obviously;
- Hypertension failed to be controlled (systolic blood pressure > 160 mmHg or diastolic pressure > 100 mmHg);
- Obvious cardiovascular disorders (eg, myocardial infarction, superior vena cava syndrome, more than two grades heart disease, or heart disease which can increase the risk of ventricular arrhythm);
- Not recover from any anticancer therapy or surgery;
- Any clinical problems beyond control (such as severe mental, neurological, cardiovascular, respiratory system diseases, etc.);
- Evidence of central nerve system metastasis;
- Have some gastrointestinal disease which can affect the distribution, metabolism or removal of this drug;
- Pregnant or breast-feeding women;
- Poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center
Guangzhou, Guangdong, 510060
Hui Lin, 0591-28059198, linhui99@sohu.com
guo l xu
About this study
The purpose of this study is to determine the safety and maximum tolerated dose of Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer and esophageal cancer).
Projected accrual: A total of 18-24 patients will be accrued for this study.
Read the detailed description
Photocyanine injection is a type of cyanine compound, which was invented in Fuzhou university by Professor Chen; it's maximum absorption wave is 670 nm. Patients receive intravenous injection of Photocyanine injection, and 24 hours later, patients undergo photodynamic therapy.
Cohorts of 3-6 patients receive escalating doses of Photocyanine Injection and photodynamic therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients experiences dose-limiting toxicity. Three additional patients are treated at the MTD.
After completion of study therapy, patients are followed for up to 2 weeks.
- Conditions
- Skin Cancer, Esophageal Cancer
- Being tested
- Photodynamic therapy
- Keywords
- skin cancer, esophageal cancer, photodynamic therapy
- Medical subject headings
- Skin Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later
| Study group | Role | What they receive |
|---|---|---|
| Photocyanine injection | Experimental | Patients receive intravenous injection of Photocyanine injection from dosage of 0.1 mg/kg,0.2 mg/kg,0.33 mg/kg,0.5 mg/kg to 0.6 6mg/kg till the dose-limiting effect occur. Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: one month
Secondary outcomes (1)
Treatment efficacy as measured by computed tomography (CT) or magnetic resonance imaging (MRI) and endoscopy exam 3 weeks after the start of study treatment according to the Response Evaluation Criteria In Solid Tumors (RECIST) standard
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Longhua Pharmaceutical Co. Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Fuzhou University, Sun Yat-sen University
- Investigators
- guo l xu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043016
- Sponsor's protocol ID
- 2008L03278
- Status last verified
- Jan 2010
- First submitted
- 4 Jan 2010
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT01043016
- Acronym / sponsor ID
- 2008L03278
- Conditions
- Skin Cancer, Esophageal Cancer
- Keywords
- skin cancer, esophageal cancer, photodynamic therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fujian Longhua Pharmaceutical Co. LtdUniversity, hospital or other
- Collaborators
- Fuzhou University, Sun Yat-sen University
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 6 Jan 2010 (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.
The purpose of this study is to determine the safety and maximum tolerated dose of Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer and esophageal cancer).
Projected accrual: A total of 18-24 patients will be accrued for this study.
Detailed description
Photocyanine injection is a type of cyanine compound, which was invented in Fuzhou university by Professor Chen; it's maximum absorption wave is 670 nm. Patients receive intravenous injection of Photocyanine injection, and 24 hours later, patients undergo photodynamic therapy.
Cohorts of 3-6 patients receive escalating doses of Photocyanine Injection and photodynamic therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients experiences dose-limiting toxicity. Three additional patients are treated at the MTD.
After completion of study therapy, patients are followed for up to 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photocyanine injection | Experimental | Procedure: Photodynamic therapyPatients receive intravenous injection of Photocyanine injection from dosage of 0.1 mg/kg,0.2 mg/kg,0.33 mg/kg,0.5 mg/kg to 0.6 6mg/kg till the dose-limiting effect occur. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 70 years old (patient over 60 years old must not have three kinds of complications of heart, lung, liver and kidney function at the same time), no gender limited;
- Advanced malignant solid tumors confirmed by histology or cytology ( skin cancer and esophageal cancer), malignant tumor can be illuminated directly (or via endoscopy) by the laser fiber;
- Recurrence after surgery, radiotherapy,chemoradiotherapy; or have financial difficulties, give up any other treatment;
- Patients received chemotherapy, biological therapy or other research drugs must exceed at least 4 weeks or more than five half-life;
- Life expectancy: > 3 months;
Key exclusion criteria (16 listed)
- No pathological evidence;
- Have allergic effect to this drug;
- HIV antibody positive, or suffering from other acquired and congenital immune deficiency diseases, or have organ transplant history;
- Neutrophil count < 1.5 × 109 / L, platelet < 100 × 109 / L, or hemoglobin < 90 g /L;
- Serum Cr above 1.5 times of normal reference range or Cr clearance rate < 50 ml/min;
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 |
|---|---|---|
| Photodynamic therapypatient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later | Procedure or surgery | Photocyanine injection |
Primary outcome
Maximum tolerated dose
Time frame: one month
1 secondary outcome
Treatment efficacy as measured by computed tomography (CT) or magnetic resonance imaging (MRI) and endoscopy exam 3 weeks after the start of study treatment according to the Response Evaluation Criteria In Solid Tumors (RECIST) standard
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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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.
Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center
Guangzhou, China
guo l xu principal investigator
Sun Yat-sen University
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 Photodynamic therapy in people with Skin Cancer and Esophageal Cancer, run by Fujian Longhua Pharmaceutical Co. Ltd at 1 site in China.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Jan 2010. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: one month). 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 6 Jan 2010.