- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813449
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 Contact
- Name: Guo Jun, PI
- Phone Number: 8610 13911233048
- Email: 1008ccl@163.com
Study Contact Backup
- Name: Cui Ch Liang, Doctor
- Phone Number: 8610 13691489319
- Email: 1008ccl@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100036
- Recruiting
- Beijing Tumor Hospital
-
Contact:
- Jun Guo, professor
- Phone Number: 8610-88121122
- Email: guoj307@126.com
-
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:
- Age > 18 years old, males or females;
- Untreated patients with advanced melanoma confirmed by histopathology or cytology;
- 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);
- 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;
- Karnofsky performance scale≥70 (appendix 1); expected survival time≥3 months;
- Patients are voluntary to participate and sign the informed contents.
Exclusion Criteria:
- Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
- With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
- 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;
- Have been treated by dacarbazine or dacarbazine included combination chemotherapy;
- Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
- Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
- Allergic to any drug in the trial;
- Patients with a second tumor;
- Patients participating in other clinical trials;
- 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
|
dacarbazine plus Endostar
Other Names:
|
Placebo Comparator: 2
Control group : Dacarbazine combined with placebo
|
dacarbazine plus placebo
Other Names:
|
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
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dacarbazine
- Endostar protein
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.
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