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

Phase 2
18 Years
75 Years
Open (Enrolling)
Advanced Melanoma, Untreated Patients

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival time , Total survival time

Outcome Time Frame:


Safety Issue:


Principal Investigator

Guo Jun, PI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Expert Committee for Melanoma of CSCO


China: Ethics Committee

Study ID:




Start Date:

August 2008

Completion Date:

August 2010

Related Keywords:

  • Advanced Melanoma
  • Untreated Patients
  • Endostar
  • advanced melanoma
  • combined chemotherapy
  • Melanoma