Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Cancer Esophageal Cancer |
Procedure: Photodynamic therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors |
- Maximum tolerated dose [ Time Frame: one month ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Photocyanine injection
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.
|
Procedure: Photodynamic therapy
patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
- No other anti-tumor treatment (including steroids);
- Patients or their legal representative can sign the informed consent;
- Performance status: ECOG ≤ 2,
Exclusion Criteria:
- 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;
- 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.
Contacts and Locations| China, Guangdong | |
| Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Hui Lin 0591-28059198 linhui99@sohu.com | |
| Principal Investigator: guo l xu | |
| Principal Investigator: | guo l xu | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors, Fujian Longhua Pharmaceutical Co. Ltd |
| ClinicalTrials.gov Identifier: | NCT01043016 History of Changes |
| Other Study ID Numbers: | 2008L03278 |
| Study First Received: | January 4, 2010 |
| Last Updated: | January 5, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Fujian Longhua Pharmaceutical Co. Ltd:
|
skin cancer esophageal cancer photodynamic therapy |
Additional relevant MeSH terms:
|
Neoplasms Skin Neoplasms Esophageal Diseases Esophageal Neoplasms Neoplasms by Site Skin Diseases |
Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013