MelanomaPhase 1/2NCT00068172
Study of PI-88 in Patients With Advanced Melanoma
A Phase 1/2 study testing PI-88 in people with Melanoma, run by Cellxpert Biotechnology Corp. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- PI-88
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jun 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Aurora, Colorado, 80010-05801
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- PI-88
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI-88Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival by RECIST criteria
Secondary outcomes (4)
Response rate
Time to progression
Overall survival
Biological activity in tumor biopsy specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2003 (estimated)
- Study startJul 2001
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants
Sponsor and investigators
- Lead sponsor
- Cellxpert Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068172
- Sponsor's protocol ID
- PR88201
- Other IDs
- PR88201A
- Status last verified
- Jun 2022
- First submitted
- 9 Sep 2003
- Last updated
- 27 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)
- ClinicalTrials.gov ID
- NCT00068172
- Acronym / sponsor ID
- PR88201
- Conditions
- Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants
- Lead sponsor
- Cellxpert Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Study start
- Jul 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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%)
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PI-88 | Drug | – |
Primary outcome
Progression-free survival by RECIST criteria
4 secondary outcomes
Response rate
Time to progression
Overall survival
Biological activity in tumor biopsy specimens
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PI-88 in people with Melanoma, run by Cellxpert Biotechnology Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival by RECIST criteria. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.