Trial of PI-88 with Dacarbazine in patients Metastatic Melanoma
- Conditions
- Metastatic melanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12607000107426
- Lead Sponsor
- Progen Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 114
1.Histologically proven metastatic melanoma2. surgery not feasible or inappropriate.3. measurable disease.4. voluntary written informed consent 5.Eastern Cooperative Oncology Group performance score 0-1. 6. at least 3 month life expectancy7. acceptable renal, liver and haematopoetic function.
1. Central Nervous System(CNS) involvement, brain or meningeal metastases2. occular melanoma3. clinically significant non malignant disease.4. Prior or co existent malignant disease5. prior chemotherapy6. prior treatment with vaccines, biological response modifiers or radiotherapy or major surgery within the previous 4 weeks7. concomitant use of aspirin, Non Steroidal antiinflammatory drugs (NSAIDs), heaprin, low molecular weight heparin, warfarin, anti platelet drugs8. heparin or low molecular weight heparin in the previous 2 weeks.9. abnormal bleeding tendancy, history of Gastrointestinal bleeding in past 2 years, Irritable bowel sydrome.10. history of cardiac problems in past 3 months11. women who are pregnant, breast feeding or women in whom pregnacy cannot be excluded.12. allergy to anti coagulants or thrombolytic agents13. history of autoimmune bleeding disorders or evidence of Anti Heparin antibodies14. uncontrolled infection within past 4 weeks15. non compliant patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the proportion of patients with objective response or stable disease[After 6 treatment cycles (approximately 18 weeks of treatment)]
- Secondary Outcome Measures
Name Time Method 1. non progression rate after 2 and 4 treatment cycles [At 6 and 12 weeks];2. Time to Progression[Weekly basis];3. Response Rate[6, 12 and 18 weeks];4. Duration of response and survival[Length of time from start of treatment to treatment end and time from treatment start until death]