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History of Changes for Study: NCT00130442
Trial of PI-88 with Dacarbazine in Patients with Metastatic Melanoma
Latest version (submitted June 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 12, 2005 None (earliest Version on record)
2 September 27, 2005 Eligibility, Outcome Measures, Study Description and Study Status
3 September 28, 2005 Study Identification and Study Status
4 April 24, 2006 Contacts/Locations and Study Status
5 February 1, 2007 Contacts/Locations and Study Status
6 February 12, 2007 Contacts/Locations and Study Status
7 June 18, 2007 Contacts/Locations, Study Status, Sponsor/Collaborators and Study Design
8 October 16, 2007 Contacts/Locations, Study Status, Eligibility and Study Design
9 April 22, 2008 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Oversight and Sponsor/Collaborators
10 November 7, 2008 Study Status and Contacts/Locations
11 March 2, 2009 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
12 March 30, 2016 Recruitment Status, Study Status, Sponsor/Collaborators, Study Design, Study Identification
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Results Submission Events
13 December 29, 2020 Study Status, Outcome Measures, Arms and Interventions, Results, Contacts/Locations and Study Design
14 June 21, 2022 Sponsor/Collaborators, Study Status and Study Identification
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Study NCT00130442
Submitted Date:  August 12, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: PR88205
Brief Title: Trial of PI-88 with Dacarbazine in Patients with Metastatic Melanoma
Official Title: A Phase II Study of PI-88 with Dacarbazine in Patients with Metastatic Melanoma
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2005
Overall Status: Recruiting
Study Start: June 2005
Primary Completion:
Study Completion: March 2007
First Submitted: August 12, 2005
First Submitted that
Met QC Criteria:
August 12, 2005
First Posted: August 15, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 12, 2005
Last Update Posted: August 15, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Progen Industries Limited
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Detailed Description: Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are limited and minimally effective. Dacarbazine is currently one of the standard chemotherapy drugs used for the treatment of metastatic melanoma. However, it is associated with low response rates (10 20%) and median survival of less than 12 months (6-11 months in most studies). PI-88 is an antiangiogenic and antimetastatic drug that has already shown some evidence of efficacy when used alone in an intermittent dosage regimen (4 consecutive days per week) in the treatment of patients with advanced melanoma. The FDA has designated PI 88 as an Orphan Drug for this indication, as well as for Stage III and high-risk stage II disease. The aim of this randomised pilot phase II trial is to determine whether PI 88 in combination with a standard regimen of dacarbazine (1000 mg/m2 every 3 weeks) should be considered for further investigation in a larger-scale trial.
Open or close this module Conditions
Conditions: Melanoma
Keywords: phase II
metastatic melanoma
dacarbazine
combination
PI-88
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 118
Open or close this module Arms and Interventions
Intervention Details:
Drug: PI-88
Drug: dacarbazine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The proportion of patients with objective response or stable disease (non-progression rate) after six treatment cycles
Secondary Outcome Measures:
1. Non-progression rate after two and four treatment cycles
2. Time to progression
3. Response rate
4. Duration of response
5. Survival
6. Descriptive statistics will be used in the analysis of safety and toxicity endpoints.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically proven metastatic melanoma
  • Surgery not feasible or inappropriate
  • Measurable disease. Metastatic lesions must be measurable by MRI or CT as defined in RECIST criteria, and cutaneous lesions by physical examination.
  • Have voluntarily given written informed consent to participate in this study
  • ECOG performance status 0 - 1
  • life expectancy at least 3 months
  • Neutrophil count > 1.5 x 109/L (1,500/mm3)
  • Platelet count > 100 x 109/L (100,000/mm3)
  • WBC > 3 x 109/L (3000/mm3)
  • Acceptable liver function tests (see Exclusion Criteria for maximum allowable elevations of ALT, AST, ALP and LDH)
  • PT < 1.5 x 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-h urine collection)

Exclusion Criteria:

  • 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
Open or close this module Contacts/Locations
Central Contact Person: Liz Wilson
Telephone: 61 7 3273 9130
Email: liz.wilson@progen.com.au
Central Contact Backup: Brian Creese, PhD
Telephone: 61 7 3273 9175
Email: brian.creese@progen.com.au
Study Officials: Michael Millward, MD
Study Chair
Sir Charles Gairdner Hospital
Anne Hamilton, PhD
Principal Investigator
Sydney Cancer Centre
Damien Thomson, MD
Principal Investigator
Princess Alexandra Hospital
Locations: Australia, New South Wales
Sydney Cancer Centre, Royal Prince Alfred Hospital
[Recruiting]
Camperdown, New South Wales, Australia, 2050
Contact:Contact: Christine Cullen +61 2 9515 7706 christine.cullen@email.cs.nsw.gov.au
Contact:Principal Investigator: Anne Hamilton, MD
Australia, Queensland
Princess Alexandra Hospital
[Recruiting]
Woolloongabba, Queensland, Australia, 4102
Contact:Contact: Steve Ivanhoe +61 7 3240 2498 Steven_Ivanhoe@health.qld.gov.au
Contact:Principal Investigator: Damien Thomson, MD
Australia, Western Australia
Sir Charles Gairdner Hospital
[Recruiting]
Perth, Western Australia, Australia, 6009
Contact:Contact: Judy Innes-Rowe 61-893463823 Judy.Innes-Rowe@health.wa.gov.au
Contact:Principal Investigator: Michael Millward, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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