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Study of PI-88 in Patients With Advanced Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of PI-88 in Patients With Advanced Melanoma

A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)

NCT00068172•Cellxpert Biotechnology Corp.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma.

Detailed Description

PI-88 is an investigational drug that works by a novel mechanism which may reduce the rate of growth of tumors, and also the spread of cancer cells around the body. It also has an effect upon blood clotting. The purpose of this study is to assess if PI-88 has any benefit to patients with advanced melanoma, as well as to gain further information on the safety of the drug. All patients in the study will receive the study drug at the same dose level. The dose of PI-88 that will be given is based on the dose that was found to be the best in the phase I portion of this study. The drug will be injected subcutaneously (under the skin) once daily for 4 days every week. Patients will be treated with PI-88 for up to 6 months, but if the drug is well tolerated and effective, patients may be offered further treatment with the drug.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Current diagnosis of metastatic melanoma, where other effective therapy is not available or has failed.
•Measurable disease. Metastatic lesions must be measurable by MRI or CT, and cutaneous lesions by physical examination.
•Aged at least 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 greater than 1.5 x 109/L (1,500/mm3)
•Calculated creatinine clearance, using the Cockcroft-Gault formula, greater than 60 mL/min. If just below 60 mL/min, then GFR greater than 60 mL/min as determined by EDTA or DTPA scan.
•Platelet count at least 100 x 109/L (100,000/mm3)
•Bilirubin less than 1.5 x ULN
+3 more criteria

Exclusion Criteria

•History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
•Chemotherapy, investigational 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 past 2 weeks.
•Uncontrolled infection or serious infection within the past 4 weeks.
•Clinically significant non-malignant disease.
•Known HIV infection or AIDS-related illness.
•Myocardial infarction, stroke or congestive heart failure within the past 3 months.
•Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
•Pregnancy, breast feeding, or women of childbearing potential in whom pregnancy cannot be excluded.
•History of abuse of alcohol, drugs, or other substances.
+5 more criteria

Locations (1)

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Key Dates

Start Date

July 1, 2001

Primary Completion Date

June 1, 2007

Completion Date

June 1, 2007

Last Updated

June 27, 2022

Enrollment

Estimated participants

Conditions

Melanoma

Interventions

PI-88

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of PI-88 in Patients With Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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