None listed
Conditions
Brief summary
This study is designed to determine the safety and efficacy of PI- 88 combined with dacarbazine as a first line treatment in patients with unresectable metastatic melanoma, compared to the current standard treatment of dacarbazine alone. PI-88 is a new drug which blocks new blood vessel growth in tumours, which starves the tumour of nutrients and therefore it cannot grow. Dacarbazine is a chemotherapy drug which has been used for many years to treat melanoma and it works by stopping the tumour cells from growing. It is hoped that by combining these two drugs patients will have better outcomes than if they were treated with dacarbazine alone. The results of this study will be analysed to see if it is worthwhile for the 2 drugs to be tested in future studies involving larger numbers of melanoma patients.
Interventions
This study will be used to determine the safety and efficacy of a new drug called PI-88 when used in combination with an approved chemotherapy drug called dacarbazine (current standard treatment) in the treatment of metastatic melanoma patients. Patients eligible to participate in this study will be randomly allocated to r
This study will be used to determine the safety and efficacy of a new drug called PI-88 when used in combination with an approved chemotherapy drug called dacarbazine (current standard treatment) in the treatment of metastatic melanoma patients. Patients eligible to participate in this study will be randomly allocated to receive the study arm: Dacarbazine (day 1 every 3 weeks 1000mg/m2 IV), plus PI- 88 (190mg) given daily via subcutaneous injection on day 1-21 inclusive in 3 week cycles. Treatment will continue for as long as benefit is shown (stable or objective response) or until patients show evidence of disease progression or are withdrawn from study treatment for other reasons. If a patient demonstrates progressive disease on the Dacarbazine alone arm they may be offered treatment with single agent PI-88 at the discretion of the Principal investigator. Patients who continue to benefit from the treatment after the initial 6 cycles of treatment will continue with the treatment. This study will continue until a minimum of 40 patients are recruited to each arm, and all patients have completed study treatment. PI-88 blocks new blood vessel growth in tumours and dacarbazine stops cancer cells from growing. the results from this study will be analysed to see if it is worthwhile for the 2 drugs to be tested in future studies involving larger numbers of melanoma patients.
Sponsors
Progen Pharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed