Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
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ClinicalTrials.gov Identifier: NCT00130442 |
Recruitment Status :
Completed
First Posted : August 15, 2005
Results First Posted : January 22, 2021
Last Update Posted : June 23, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Drug: PI-88 and dacarbazine Drug: dacarbazine or DTIC | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1- PI-88 plus dacarbazine
PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle
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Drug: 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 |
Active Comparator: Arm 2- dacarbazine alone
dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion
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Drug: dacarbazine or DTIC
intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle |
- Non-progression Rate After Six Cycles [ Time Frame: In week 3 of every second cycle (each cycle was 21 days) for all subjects enrolled, up to the end of cycle 6 (About 5 months after randomization) ]The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after six treatment cycles
- Non-progression Rate [ Time Frame: In week 3 of every second cycle (each cycle was 21 days) for all subjects enrolled in cycle 2 and cycle 4. ]The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after 2 or 4 treatment cycles
- Time to Progression [ Time Frame: At screening and in week 3 of every second cycle up to the end of cycle 6 and every third cycle after cycle 6 . Each cycle was 21 days.Assessed from date of randomization until the date of first documented progression, up to 50 months. ]treatment was to continue until the subject experienced disease progression.
- Duration of Response [ Time Frame: At screening and in week 3 of every second cycle up to the end of cycle 6 and every third cycle after cycle 6. Each cycle was 21 days. Assessed from date of randomization until the date of first documented progression, up to 50 months. ]time from commencement to radiological evidence of progression
- Survival [ Time Frame: It was to assess time to death. The time frame is at least 6th month, 12th month and data was continuously collected till the end of the study, up to 50 months.. ]time to death and also at time-points 6 month and 12 months

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130442
United States, Arizona | |
Arizona Cancer Centre | |
Tucson, Arizona, United States, 85724 | |
United States, Colorado | |
University of Colorado Health Science Centre | |
Denver, Colorado, United States, 80010-0510 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6307 | |
Australia, New South Wales | |
Sydney Cancer Centre, Royal Prince Alfred Hospital | |
Camperdown, New South Wales, Australia, 2050 | |
Westmead Institute for Cancer Research | |
Sydney, New South Wales, Australia, 2145 | |
Australia, Queensland | |
Wesley Research Institute | |
Auchenflower, Queensland, Australia, 4066 | |
Townsville Cancer Centre | |
Townsville, Queensland, Australia, 4814 | |
Princess Alexandra Hospital | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
The Queen Elizabeth Hospital | |
Woodville, South Australia, Australia, 5011 | |
Australia, Victoria | |
Border Medical Oncology | |
Wodonga, Victoria, Australia, 3690 | |
Australia, Western Australia | |
Royal Perth Hospital | |
Perth, Western Australia, Australia, 6001 | |
Sir Charles Gairdner Hospital | |
Perth, Western Australia, Australia, 6009 |
Study Chair: | Michael Millward, MD | Sir Charles Gairdner Hospital | |
Principal Investigator: | Anne Hamilton, PhD | Sydney Cancer Centre | |
Principal Investigator: | Damien Thomson, MD | Princess Alexandra Hospital |
Responsible Party: | Cellxpert Biotechnology Corp. |
ClinicalTrials.gov Identifier: | NCT00130442 |
Obsolete Identifiers: | NCT00128648 |
Other Study ID Numbers: |
PR88205 |
First Posted: | August 15, 2005 Key Record Dates |
Results First Posted: | January 22, 2021 |
Last Update Posted: | June 23, 2022 |
Last Verified: | June 2022 |
phase II metastatic melanoma dacarbazine combination PI-88 |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |