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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00813449
First received: December 19, 2008
Last updated: December 6, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Advanced Melanoma
Untreated Patients
Drug: dacarbazine plus Endostar (Experimental group)
Drug: dacarbazine plus placebo (control group)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Progression-free survival time , Total survival time [ Time Frame: 2010.8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate , Disease controlled rate and adverse effects [ Time Frame: 2009.8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Experimental group : Endostar combined with dacarbazine
Drug: dacarbazine plus Endostar (Experimental group)
dacarbazine plus Endostar
Other Name: dacarbazine plus Endostar
Placebo Comparator: 2
Control group : Dacarbazine combined with placebo
Drug: dacarbazine plus placebo (control group)
dacarbazine plus placebo
Other Name: dacarbazine plus placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813449

Contacts
Contact: Guo Jun, PI 13911233048 ext 8610 1008ccl@163.com
Contact: Cui Ch Liang, Doctor 13691489319 ext 8610 1008ccl@163.com

Locations
China, Beijing
Beijing tumor hospital Recruiting
Beijing, Beijing, China, 100036
Contact: Jun Guo, professor    8610-88121122    guoj307@126.com   
Contact: liang ch Cui, doctor    8610-88121122      
Principal Investigator: Jun Guo, professor         
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Guo Jun, PI Expert Committee for Melanoma of CSCO
  More Information

Additional Information:
No publications provided

Responsible Party: Guo Jun, Expert Committee for Melanoma of CSCO
ClinicalTrials.gov Identifier: NCT00813449     History of Changes
Other Study ID Numbers: simcere001, simcere0801
Study First Received: December 19, 2008
Last Updated: December 6, 2009
Health Authority: China: Ethics Committee
United States: Institutional Review Board

Keywords provided by Simcere Pharmaceutical Co., Ltd:
Endostar
advanced melanoma
combined chemotherapy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Endostatins
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014