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

DISEASE CHARACTERISTICS: Phase I Histologically or cytologically confirmed malignancy No other effective treatment available OR failed prior therapy No prior or concurrent symptomatic or known CNS involvement or brain or meningeal metastases Phase II Diagnosis of stage IV melanoma Metastatic disease must be measurable No other effective treatment available OR failed prior therapy Asymptomatic brain metastases allowed provided patient is off steroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 70-100% Life expectancy At least 3 months Hematopoietic Neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Negative serotonin release assay test for anti-heparin antibodies No other abnormal bleeding tendency No history of heparin-induced thrombocytopenia No history of immune-mediated thrombocytopenia No history of thrombolytic thrombocytopenic purpura No history of other platelet disease Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN (5 times ULN if liver metastases are present) PTT normal (20-34 sec) PT less than 1.5 times ULN Renal Creatinine clearance greater than 60 mL/min OR Glomerular filtration rate greater than 60 mL/min Cardiovascular No myocardial infarction within the past 3 months No stroke within the past 3 months No congestive heart failure within the past 3 months Gastrointestinal No history of acute or chronic gastrointestinal bleeding within the past 2 years No inflammatory bowel disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No AIDS-related illness No serious infection within the past 4 weeks No history of alcohol, drug, or other substance abuse No history of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents (e.g., heparin) No risk of bleeding due to open wounds or planned surgery No clinically significant nonmalignant disease No uncontrolled infection Inclusion Criteria 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. Exclusion Criteria 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) Concurrent palliative radiotherapy allowed Surgery Recovered from prior major surgery No concurrent surgery Other More than 2 weeks since prior heparin or low-molecular weight heparin More than 4 weeks since other prior investigational therapy No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent aspirin or aspirin-containing medications No concurrent nonsteroidal anti-inflammatory drugs Concurrent cyclooxygenase-2 inhibitors allowed No concurrent heparin or low-molecular weight heparin No concurrent warfarin or warfarin-containing medications No other concurrent anticoagulant medications