NCT01043016

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 4, 2010

Last Update Submit

January 5, 2010

Conditions

Skin CancerEsophageal Cancer

Keywords

skin canceresophageal cancerphotodynamic therapy

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    one month

Secondary Outcomes (1)

  • 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

    six weeks

Study Arms (1)

Photocyanine injection

EXPERIMENTAL

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

Interventions

Photodynamic therapyPROCEDURE

patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later

Photocyanine injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Skin NeoplasmsEsophageal Neoplasms

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • guo l xu

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 6, 2010

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

CN(1)