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

• Status: Unknown status
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Treatments: Dacarbazine; Endostar protein

Criteria

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