Safety Study of Combined Chemotherapy and Endostar to Untreated Patients With Advanced Melanoma (melanoma)

December 6, 2009 updated by: Simcere Pharmaceutical Co., Ltd

Multicenter, Double-blinding, Randomized Controlled, Phase II Clinical Trial on Combined Chemotherapy of Endostar (Recombinant Human Endostatin) for Untreated Patients With Advanced Melanoma

Multicenter, double-blinding, randomized controlled, phase II clinical trial on combined chemotherapy of Endostar (Recombinant Human Endostatin) for untreated patients with advanced melanoma, To compare the efficacy and safety of Endostar combined with Dacarbazine and monotherapy of Dacarbazine for advanced melanoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and as a single agent gives a response rate of about 20%. There have been efforts to ameliorate this poor result by using DTIC in different combinations without a significant improvement. In addition, new studies with melanoma cells in vitro show that DTIC combination with Endostar, suggesting a potential clinical benefit from the concomitant treatment of DTIC and antiangiogenesis therapy. Endostar is a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. The purpose of this study is to determine whether a combination therapy of endostar and DTIC is safe and can increase response rate and progression-free survival in patients (pts) with metastatic melanoma. We will evaluate the efficacy and safety of the Endostar plus DTIC and hope provide a new hope for the advanced melanoma patients.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

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, 100036
        • Recruiting
        • Beijing Tumor Hospital
        • Contact:
        • Contact:
          • liang ch Cui, doctor
          • Phone Number: 8610-88121122
        • Principal Investigator:
          • Jun Guo, Professor

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18 years old, males or females;
  2. Untreated patients with advanced melanoma confirmed by histopathology or cytology;
  3. With tumor foci that can be evaluated by CT or MRI; at least one diameter ≥ 1 cm (including metastatic lymph nodes, diameter ≥ 1 cm confirmed by CT scan); or superficial focus ≥ 2 cm (confirmed by photos with calibration);
  4. No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤2.5×UNL; Hepatic function: transaminase≤2.5×UNL, or ≤5×UNL in patients with liver metastasis;
  5. Karnofsky performance scale≥70 (appendix 1); expected survival time≥3 months;
  6. Patients are voluntary to participate and sign the informed contents.

Exclusion Criteria:

  1. Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
  2. With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
  3. With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;
  4. Have been treated by dacarbazine or dacarbazine included combination chemotherapy;
  5. Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
  6. Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
  7. Allergic to any drug in the trial;
  8. Patients with a second tumor;
  9. Patients participating in other clinical trials;
  10. Other conditions that are regarded for exclusion by the trialists

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Experimental group : Endostar combined with dacarbazine
Drug: dacarbazine plus Endostar (Experimental group)
dacarbazine plus Endostar
Other Names:
  • dacarbazine plus Endostar
Placebo Comparator: 2
Control group : Dacarbazine combined with placebo
Drug: dacarbazine plus placebo (control group)
dacarbazine plus placebo
Other Names:
  • dacarbazine plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival time , Total survival time
Time Frame: 2010.8
2010.8

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response rate , Disease controlled rate and adverse effects
Time Frame: 2009.8
2009.8

Collaborators and Investigators

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

Sponsor

Simcere Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Guo Jun, PI, Expert Committee for Melanoma of CSCO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

August 1, 2008

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 8, 2009

Last Update Submitted That Met QC Criteria

December 6, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • simcere001
  • simcere0801

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.

Clinical Trials on Advanced Melanoma

Clinical Trials on dacarbazine plus Endostar (Experimental group)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe