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Trial registered on ANZCTR


Registration number
ACTRN12607000107426
Ethics application status
Approved
Date submitted
2/02/2007
Date registered
6/02/2007
Date last updated
1/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of PI-88 with Dacarbazine in patients Metastatic Melanoma
Scientific title
A randomised phase II study to determine the safety and efficacy of PI-88 plus Dacarbazine compared to Dacarbazine alone in Patients with Metastatic Melanoma
Secondary ID [1] 339 0
ClinicalTrials.gov: NCT00130442
Universal Trial Number (UTN)
Trial acronym
PR88205
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic melanoma 1601 0
Condition category
Condition code
Cancer 1704 1704 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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long as benefit is shown (stable or objective response) or until patients show evidence of disease progression or are withdrawn from study treatment for other reasons.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.
Intervention code [1] 1584 0
Treatment: Drugs
Comparator / control treatment
Dacarbazine alone (1000 mg/m2), via intravenous infusion (IV) over 1 hour on day 1 of a 3 week treatment cycle
Control group
Active

Outcomes
Primary outcome [1] 2372 0
To determine the proportion of patients with objective response or stable disease
Timepoint [1] 2372 0
After 6 treatment cycles (approximately 18 weeks of treatment)
Secondary outcome [1] 4123 0
1. non progression rate after 2 and 4 treatment cycles
Timepoint [1] 4123 0
At 6 and 12 weeks
Secondary outcome [2] 4124 0
2. Time to Progression
Timepoint [2] 4124 0
Weekly basis
Secondary outcome [3] 4125 0
3. Response Rate
Timepoint [3] 4125 0
6, 12 and 18 weeks
Secondary outcome [4] 5800 0
4. Duration of response and survival
Timepoint [4] 5800 0
Length of time from start of treatment to treatment end and time from treatment start until death

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by "sealed opaque envelopes"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 479 0
United States of America
State/province [1] 479 0
Colorado

Funding & Sponsors
Funding source category [1] 1850 0
Commercial sector/Industry
Name [1] 1850 0
Progen Pharmaceuticals Ltd
Address [1] 1850 0
16 Benson Street, Toowong 4066
Country [1] 1850 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Progen Pharmaceuticals Ltd
Address
16 Benson Street
Toowong QLD 4066
Country
Australia
Secondary sponsor category [1] 1665 0
None
Name [1] 1665 0
N/A
Address [1] 1665 0
Country [1] 1665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3449 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 3449 0
Nedlands, WA
Ethics committee country [1] 3449 0
Australia
Date submitted for ethics approval [1] 3449 0
Approval date [1] 3449 0
Ethics approval number [1] 3449 0
MP/frn/Ethics 2005
Ethics committee name [2] 3450 0
Princess Alexandra Hospital
Ethics committee address [2] 3450 0
Wooloongabba, Qld
Ethics committee country [2] 3450 0
Australia
Date submitted for ethics approval [2] 3450 0
Approval date [2] 3450 0
Ethics approval number [2] 3450 0
2005/31
Ethics committee name [3] 3451 0
Royal Prince Alfred Hospital
Ethics committee address [3] 3451 0
Ethics committee country [3] 3451 0
Australia
Date submitted for ethics approval [3] 3451 0
Approval date [3] 3451 0
Ethics approval number [3] 3451 0
X050046
Ethics committee name [4] 3452 0
Royal Perth Hospital
Ethics committee address [4] 3452 0
Perth WA
Ethics committee country [4] 3452 0
Australia
Date submitted for ethics approval [4] 3452 0
Approval date [4] 3452 0
Ethics approval number [4] 3452 0
EC RA 05/01
Ethics committee name [5] 3453 0
The Queen Elizabeth Hospital
Ethics committee address [5] 3453 0
Woodville, SA
Ethics committee country [5] 3453 0
Australia
Date submitted for ethics approval [5] 3453 0
Approval date [5] 3453 0
Ethics approval number [5] 3453 0
2006 057
Ethics committee name [6] 3454 0
Border Medical Oncology
Ethics committee address [6] 3454 0
Wodonga, Vic
Ethics committee country [6] 3454 0
Australia
Date submitted for ethics approval [6] 3454 0
Approval date [6] 3454 0
Ethics approval number [6] 3454 0
Ethics committee name [7] 3455 0
Arizona Cancer Centre
Ethics committee address [7] 3455 0
Tuscon Arizona
Ethics committee country [7] 3455 0
United States of America
Date submitted for ethics approval [7] 3455 0
Approval date [7] 3455 0
Ethics approval number [7] 3455 0
BIO # 06- 131
Ethics committee name [8] 3456 0
University of Colorado Health Science Centre
Ethics committee address [8] 3456 0
Denver Colorado
Ethics committee country [8] 3456 0
United States of America
Date submitted for ethics approval [8] 3456 0
Approval date [8] 3456 0
Ethics approval number [8] 3456 0
05- 0226
Ethics committee name [9] 6124 0
Westmead Hospital
Ethics committee address [9] 6124 0
Hawkesbury Road, Westmead Hospital, Westmead, NSW, 2145
Ethics committee country [9] 6124 0
Australia
Date submitted for ethics approval [9] 6124 0
Approval date [9] 6124 0
14/07/2008
Ethics approval number [9] 6124 0
HREC 2009/5/4.1 (2781)

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27518 0
Address 27518 0
Country 27518 0
Phone 27518 0
Fax 27518 0
Email 27518 0
Contact person for public queries
Name 10773 0
Barbara Hicks
Address 10773 0
Progen Pharmaceuticals Ltd 16 Benson Street Toowong 4066 Brisbane
Country 10773 0
Australia
Phone 10773 0
+61 7 3842 3333
Fax 10773 0
3720 9587
Email 10773 0
patient.enquiries@progen-pharma.com
Contact person for scientific queries
Name 1701 0
Barbara Hicks
Address 1701 0
Progen Industries Ltd
16 Benson Street
Toowong QLD 4066
Country 1701 0
Australia
Phone 1701 0
+61 7 3842 3333
Fax 1701 0
Email 1701 0
barbarah@progen-pharma.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary