Skin Cancer | Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
Skin Cancer research study
What is the primary objective of 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.
Who is eligible to participate?
Inclusion Criteria: 1. 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; 2. 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; 3. Recurrence after surgery, radiotherapy,chemoradiotherapy; or have financial difficulties, give up any other treatment; 4. Patients received chemotherapy, biological therapy or other research drugs must exceed at least 4 weeks or more than five half-life; 5. Life expectancy: > 3 months; 6. Can collaboratively observe the adverse events and efficacy; 7. No other anti-tumor treatment (including steroids); 8. Patients or their legal representative can sign the informed consent; 9. Performance status: ECOG ≤ 2, Exclusion Criteria: 1. No pathological evidence; 2. Have allergic effect to this drug; 3. HIV antibody positive, or suffering from other acquired and congenital immune deficiency diseases, or have organ transplant history; 4. Neutrophil count < 1.5 × 109 / L, platelet < 100 × 109 / L, or hemoglobin < 90 g /L; 5. Serum Cr above 1.5 times of normal reference range or Cr clearance rate < 50 ml/min; 6. 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; 7. Serum bilirubin > 1.5 times of the normal range; 8. Fever above 38 ℃, or have active infection which can affect the clinical trials obviously; 9. Hypertension failed to be controlled (systolic blood pressure > 160 mmHg or diastolic pressure > 100 mmHg); 10. 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); 11. Not recover from any anticancer therapy or surgery; 12. Any clinical problems beyond control (such as severe mental, neurological, cardiovascular, respiratory system diseases, etc.); 13. Evidence of central nerve system metastasis; 14. Have some gastrointestinal disease which can affect the distribution, metabolism or removal of this drug; 15. Pregnant or breast-feeding women; 16. Poor compliance.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Photodynamic therapypatient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Photocyanine injectionPatients 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.
Start Date: March 2009
Completed Date: April 2010
Phase: Phase 1
Primary Outcome: Maximum tolerated dose
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
Study sponsors, principal investigator, and references
Principal Investigator: guo l xu
Lead Sponsor: Fujian Longhua Pharmaceutical Co. Ltd
Collaborator: Fuzhou University