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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Fujian Longhua Pharmaceutical Co. Ltd.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fuzhou University
Sun Yat-sen University
Information provided by:
Fujian Longhua Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01043016
First received: January 4, 2010
Last updated: January 5, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Fujian Longhua Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043016

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         
Sponsors and Collaborators
Fujian Longhua Pharmaceutical Co. Ltd
Fuzhou University
Sun Yat-sen University
Investigators
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:
Skin Neoplasms
Esophageal Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014