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

January 5, 2010 updated by: Fujian Longhua Pharmaceutical Co. Ltd

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center
        • Contact:
        • Principal Investigator:
          • guo l xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Longhua Pharmaceutical Co. Ltd

Collaborators

Sun Yat-sen University
Fuzhou University

Investigators

  • Principal Investigator: guo l xu, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008L03278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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