Completed

A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)

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What is being tested

PI-88

Drug
Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorCellxpert Biotechnology Corp.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Phase I * Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy. * Determine the safety and tolerability of this drug in these patients. Phase II * Determine the progression-free survival and time to progression in patients with stage IV melanoma treated with this drug. * Determine the biological activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. * Phase I (parts 1 and 2): * Part 1: Patients receive PI-88 subcutaneously (SC) once daily on days 1-4 and 15-18. Cohorts of 3-6 patients receive escalating doses of PI-88 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined in part I, the effect of dose frequency is determined in patients in part II. * Part 2: Patients receive PI-88 SC once daily on days 1-4, 8-11, 15-18, and 22-25 at a dose based on the MTD determined in part 1. Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is determined. * Phase II (patients with metastatic melanoma): Patients receive PI-88 as in phase I, part 2 at the MTD. Treatment in both phases repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-69 patients (18-30 for phase I \[part 1\], 6-9 for phase I \[part 2\], and 25-30 for phase II) will be accrued for this study.

Official TitleA Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II) 
NCT00073892
Principal SponsorCellxpert Biotechnology Corp.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
44 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive four consecutive days treatment each week in a 4-week cycle.

250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
Study Objectives
Primary Objectives

non-progression rate (objective response or stable disease)
Secondary Objectives

time to progression and overall survival

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
University of Colorado Cancer Center at University of Colorado Health Sciences CenterAurora, United StatesSee the location
Suspended
Princess Alexandra HospitalBrisbane, Australia
Suspended
Queen Elizabeth HospitalWoodville, Australia
Suspended
Alfred HospitalMelbourne, Australia
Completed5 Study Centers