PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma

Completed · Phase 1/Phase 2

Conditions studied: Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific

In brief

RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.

Key facts

Study ID

NCT00073892

Run by

Cellxpert Biotechnology Corp.

People needed

44

Starts

2004-01-01

Expected to finish

2005-11-01

Last updated by the study team

2022-06-27

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current diagnosis of metastatic melanoma, where other effective therapy was not available or had failed.
• Measurable disease. Metastatic lesions had to have been measurable by MRI or CT, and cutaneous lesions by physical examination.
• Biopsiable Lesion Group only: Must have had at least one biopsiable lesion that was bi-dimensionally measurable and previously unirradiated.
• Age≥ 18 years.
• Have voluntarily given written informed consent to participate in this study.
• Performance status: ECOG 0 - 2 (Karnofsky 70 -100%).
• Life expectancy of at least 3 months.
• Neutrophil count > 1.5 x 109/L (1,500/mm3).
• Platelet count > 100 x 109/L (100,000/mm3).
• APTT normal (20 - 34 sec).
• PT <1.5 x ULN.
• Calculated creatinine clearance, using the Cockcroft-Gault formula, >60 mL/min. If just below 60 mL/min, then GFR>60 mL/min as determined by EDTA or DTPA scan.
• Bilirubin <1.5 x ULN.
• AST and ALT up to 2 x ULN; except in the presence of liver metastases; up to 5 x ULN.

You may not qualify if…

• Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
• Concomitant use of aspirin (> 100 mg/day), non-steroidal anti-inflammatory drugs (with the exception of COX-2 inhibitors), heparin, low molecular weight heparin or warfarin (> 1 mg/day) which was ongoing or anticipated during the study period. Low-dose aspirin (100 mg/day or less) or low-dose warfarin (1 mg/day or less) was permitted.
• Heparin or low molecular weight heparin within the previous 2 weeks.
• Chemotherapy, investigational therapy or hormonal therapy in the previous 4 weeks.
• Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the previous 2 weeks.
• History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
• History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura and/or other platelet diseases, or laboratory evidence of anti-heparin antibodies.
• Myocardial infarction, stroke or congestive heart failure within the previous 3 months
• History of acute or chronic gastrointestinal bleeding within the previous two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
• Uncontrolled infection or serious infection within the previous 4 weeks.
• Clinically significant non-malignant disease.
• Known AIDS-related illness or HIV positive.
• Women who were pregnant, breast feeding, or of childbearing potential in whom pregnancy could not be excluded.
• History of abuse of alcohol, drugs or other substances.
• Not recovered from major surgery if conducted prior to the study.
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• More than 4 weeks since prior chemotherapy
• Endocrine therapy
• More than 4 weeks since prior hormonal therapy
• Radiotherapy
• More than 2 weeks since prior radiotherapy
• More than 4 weeks since prior radiotherapy to a major bone-marrow bearing area (e.g., pelvis, femoral heads, or lumbar-sacral spine)

Where it is running

• University of Colorado Cancer Center at University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Princess Alexandra Hospital — Brisbane, Queensland, Australia
• Queen Elizabeth Hospital — Woodville, South Australia, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital - Perth — Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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