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UNKNOWNPHASE1

Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors

NCT01043016•Fujian Longhua Pharmaceutical Co. Ltd

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.

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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);
+6 more criteria

Locations (1)

Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

March 1, 2009

Primary Completion Date

March 1, 2010

Completion Date

April 1, 2010

Last Updated

January 6, 2010

Enrollment

ESTIMATED participants

Conditions

Skin CancerEsophageal Cancer

Interventions

Photodynamic therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors

Inclusion Criteria

Exclusion Criteria

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