Study of PI-88 in Patients With Advanced Melanoma

Phase 1

Completed

• Conditions: Melanoma

• Registration Number: NCT00068172
• Lead Sponsor: Cellxpert Biotechnology Corp.

Brief 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.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2003-09-09
• Study First Submitted QC: 2003-09-09
• Study First Posted: 2003-09-10
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival by RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Overall survival
Response rate
Time to progression
Biological activity in tumor biopsy specimens

Trial Locations

Locations (1)

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States