A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites

August 29, 2017 updated by: Quanwang Li, Dongfang Hospital Beijing University of Chinese Medicine

Single-arm, Non-randomized, Open, Drug Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion Treatment on Digestive System Cancer Patients With Ascites

To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. The clinical trial is divided into two parts, including single and successive administration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. A single-arm, non-randomized, open, drug tolerance trial will be conducted. The clinical trial is divided into two parts, including single and successive administration.The single administration includes 7 groups, dose is escalated from 15ml to 180ml, with 2-6 patients per dose level. Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. This treatment will be given only once, and the volunteers will be observed for 24 hours. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc. The successive administration includes 2 groups, according to the result of single administration, choose the second largest tolerance dose to conduct the 1st group of successive administration. If there are significant adverse effects, then drop to a lower dose to conduct the 2nd group; if the trial shows no adverse effects, it upgrades to a higher dose (the maximum tolerated dose) to conduct the 2nd group. The treatment will be given 3 times a week, 2 weeks as a period. Adverse effects will be evaluated during and after treatment.

Study Type

Interventional

Enrollment (Anticipated)

48

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
    • Beijing
      • Beijing, Beijing, China, 100078
        • Recruiting
        • Oncology dept; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
        • Contact:
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. digestive system cancer with malignant ascites;
  2. the age of 18-80 years;
  3. neither systemic chemotherapy, nor peritoneal perfusion therapy in 2 weeks;
  4. no cinobufotalin preparations in 2 weeks;
  5. ECOG score 0-3;
  6. the amount of ascites is above level II (1000-3000ml);
  7. volunteer to participate and sign informed consent.

Exclusion Criteria:

  1. non-cancer causes of ascites, such as peritonitis, cirrhosis，hypoalbuminemia;
  2. Had an allergy history to toad's skin or its products or had adverse reactions like arrhythmia when applied before;
  3. B ultrasound or CT confirmed the peritoneal cavity is separated which will affect the treatment of ascites and the estimation of ascites;
  4. The conditions admit and the patients would better to undergo chemotherapy of malignant ascites;
  5. cardiac function is Ⅲ-Ⅳ;
  6. ALT> 3 times upper limit and / or TBIL> 2 times upper limit;
  7. renal function is phase 3 and above 3;
  8. have severe neutropenia of degree II or above, and / or moderate or severe anemia, and / or thrombocytopenia of degree II or above;
  9. Consolidated mental disorders.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cinobufacini group
48 patients(half males and half females) will be in the group.Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc.
Drug: Cinobufacini Injection
Cinobufacini injection is extracted from a traditional Chinese medicine Bufo toad skins, it's something cold and poisonous with damp evil. On one hand it can kill the cancer cells direct; on the other hand it has the ability to contract blood vessels and inhibit the formation of tumor new vessels. It has been widely used in the treatment of various malignancies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the grade of adverse events
Time Frame: 14 days
According to The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 4.0)，grade the severity of adverse events (AE) that occur with drug treatment，which include symptoms, electrocardiogram, blood routine, urine routine, hepatic and renal function. Each item is graded 1-5.
14 days

Collaborators and Investigators

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

Sponsor

Dongfang Hospital Beijing University of Chinese Medicine

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

July 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-XTCX-05

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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