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

Advanced Melanoma Clinical Trial

— melanoma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00813449
• Other study ID #: simcere001
• Secondary ID: simcere0801
• Status: Recruiting
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: December 6, 2009
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2009
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Guo Jun, PI
• Phone: 13911233048
• Email: 1008ccl[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma
• Untreated Patients

Intervention

Drug:
• dacarbazine plus Endostar (Experimental group)
dacarbazine plus Endostar
• dacarbazine plus placebo (control group)
dacarbazine plus placebo

Locations

Country	Name	City	State
China	Beijing tumor hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival time , Total survival time		2010.8	No
Secondary	Tumor response rate , Disease controlled rate and adverse effects		2009.8	No

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