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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00130442




Registration number
NCT00130442
Ethics application status
Date submitted
12/08/2005
Date registered
15/08/2005
Date last updated
31/03/2016

Titles & IDs
Public title
Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
Scientific title
A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
Secondary ID [1] 0 0
PR88205
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PI-88 and dacarbazine
Treatment: Drugs - dacarbazine or DTIC

Experimental: 1 - PI-88 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle

Active Comparator: 2 - dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion


Treatment: Drugs: PI-88 and dacarbazine
190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion

Treatment: Drugs: dacarbazine or DTIC
intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients with objective response or stable disease (non-progression rate) after six treatment cycles
Timepoint [1] 0 0
after six treatment cycles
Secondary outcome [1] 0 0
Non-progression rate after two and four treatment cycles
Timepoint [1] 0 0
after two treatment cycles and after four treatment cycles
Secondary outcome [2] 0 0
Time to progression
Timepoint [2] 0 0
at the point of first radiological evidence of progressive disease
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
time from commencement to radiological evidence of progression
Secondary outcome [4] 0 0
Survival
Timepoint [4] 0 0
time to death and also at time-points 6 month and 12 months

Eligibility
Key inclusion criteria
- Histologically proven metastatic melanoma

- Surgery not feasible or inappropriate

- Measurable disease. Metastatic lesions must be measurable by magnetic resonance
imaging (MRI) or computed tomography (CT) as defined in Response Evaluation Criteria
in Solid Tumors (RECIST), and cutaneous lesions by physical examination.

- Have voluntarily given written informed consent to participate in this study

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1

- Life expectancy at least 3 months

- Neutrophil count > 1.5 x 10^9/L (1,500/mm3)

- Platelet count > 100 x 10^9/L (100,000/mm3)

- Acceptable liver function tests (see
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for maximum allowable
elevations of ALT, AST, ALP and LDH)

- PT < 1.5 x upper limit of normal (ULN)

- APTT < 1.5 x ULN

- Creatinine clearance > 40 mL/min, calculated using the Cockcroft-Gault formula (if
just below 40 mL/min, then GFR > 40 mL/min as determined by 24-hour urine collection)



- Current or history of central nervous system involvement, brain or meningeal
metastases

- Ocular melanoma

- Clinically significant non-malignant disease

- Prior or co-existent malignancies (other than stage I internal malignancy where
treated and disease-free for > 5 years, non-melanomatous skin cancer or in situ cancer
of the cervix)

- Prior chemotherapy

- Prior treatment with vaccines and/or biological response modifiers within the previous
4 weeks

- Prior treatment with radiotherapy within the previous 4 weeks (local palliative
radiotherapy is permitted)

- Radiotherapy to > 30% of marrow-bearing bone within the previous 3 months

- Major surgery within the past 4 weeks

- Concomitant use of aspirin (> 150 mg/day), non-steroidal anti-inflammatory drugs
(except specific COX-2 inhibitors), heparin, low molecular weight heparin, warfarin (>
1 mg/day) or anti-platelet drugs (abciximab, clopidogrel, dipyridamole, ticlopidine
and tirofiban). Low-dose aspirin (= 150 mg/day) and low-dose warfarin (= 1 mg/day) are
permitted as concomitant medications.

- Heparin or low molecular weight heparin within the previous 2 weeks

- History of acute or chronic gastrointestinal bleeding within the last 2 years,
inflammatory bowel disease or other abnormal bleeding tendency

- Patients at risk of bleeding due to open wounds or planned surgery

- Bilirubin > 1.5 x ULN

- AST or ALT > 3 x ULN unless patient has hepatic metastases

- LDH > 2 x ULN

- Alkaline phosphatase > 5 x ULN, unless patient has bone metastases

- Myocardial infarction, stroke or congestive heart failure within the past 3 months

- Women who are pregnant or breast feeding

- Women of childbearing potential in whom pregnancy cannot be excluded or who are not
using an adequate method of contraception

- History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents,
especially heparin

- History of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or
other platelet disease, or laboratory evidence of anti-heparin antibodies

- Uncontrolled or serious infection within the past 4 weeks

- Patients who are unable to be compliant or to follow instructions given to them by
clinic staff

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Cancer Centre, Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research - Sydney
Recruitment hospital [3] 0 0
Wesley Research Institute - Auchenflower
Recruitment hospital [4] 0 0
Townsville Cancer Centre - Townsville
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [7] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4814 - Townsville
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3690 - Wodonga
Recruitment postcode(s) [8] 0 0
6001 - Perth
Recruitment postcode(s) [9] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medigen Biotechnology Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Progen Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to compare the safety and effectiveness of a new drug called PI-88,
when used in combination with an approved chemotherapy drug called dacarbazine, in the
treatment of metastatic melanoma.

PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine
stops the cancer cells from growing. The results from this study will be analysed to see if
it is worthwhile for the two drugs to be tested in future studies involving larger numbers of
melanoma patients.
Trial website
https://clinicaltrials.gov/show/NCT00130442
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Millward, MD
Address 0 0
Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications