- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068172
Study of PI-88 in Patients With Advanced Melanoma
June 21, 2022 updated by: Cellxpert Biotechnology Corp.
A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)
The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma.
Study Overview
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.
Study Type
Interventional
Enrollment
88
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80010-05801
- University of Colorado Health Sciences Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- AST and ALT up to 2 x ULN, except in the presence of liver metastases; up to 5 x ULN.
- Prothrombin time less than 1.5 x ULN
- APTT normal (20 - 34 sec)
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.
- History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
- Concomitant use of aspirin (more than 100 mg/day), non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) is ongoing or anticipated during the study period. Low-dose aspirin (up to 100 mg/day) or low-dose warfarin (up to 1 mg/day) is permissible.
- Heparin or low molecular weight heparin within the previous 2 weeks.
- Not recovered from major surgery if conducted prior to the study.
- History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Progression-free survival by RECIST criteria
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Secondary Outcome Measures
Outcome Measure |
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Time to progression
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Response rate
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Overall survival
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Biological activity in tumor biopsy specimens
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 9, 2003
First Submitted That Met QC Criteria
September 9, 2003
First Posted (Estimate)
September 10, 2003
Study Record Updates
Last Update Posted (Actual)
June 27, 2022
Last Update Submitted That Met QC Criteria
June 21, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR88201
- PR88201A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
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Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
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BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on PI-88
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Progen PharmaceuticalsTerminatedCancer | Hepatocellular Carcinoma | Primary Liver Cancer | Liver Cancer | HepatomaHong Kong, Singapore, United States, Australia, Canada, Italy, Malaysia, Spain, Taiwan, Thailand
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Cellxpert Biotechnology Corp.Medigen Biotechnology CorporationTerminatedCancer | Hepatocellular Carcinoma | Liver CancerKorea, Republic of, Taiwan, Hong Kong, China
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Cellxpert Biotechnology Corp.Medigen Biotechnology CorporationCompleted
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Cellxpert Biotechnology Corp.Medigen Biotechnology CorporationCompletedCarcinoma, Non-Small-Cell LungAustralia
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-
University Tunis El ManarUnknown
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