Melanoma (Skin)Phase 1/2NCT00073892
PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
A Phase 1/2 study testing PI-88 in people with Melanoma (Skin) and Unspecified Adult Solid Tumor, Protocol Specific, run by Cellxpert Biotechnology Corp. at 5 sites in 2 countries.
Trial summary
RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- PI-88
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2004to Nov 2005
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Alfred Hospital
Melbourne, Victoria, 3004
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, 6009
Queen Elizabeth Hospital
Woodville, South Australia, 5011
United States1 site
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
About this study
Official title: A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)
RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.
Read the detailed description
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.
- Being tested
- PI-88
- Keywords
- unspecified adult solid tumor, protocol specific, stage IV melanoma, recurrent melanoma
- 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
Also called Mannopentaose phosphate sulfate
250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
| Study group | Role | What they receive |
|---|---|---|
| PI-88 | Experimental | Patients receive four consecutive days treatment each week in a 4-week cycle. Receives: Drug: PI-88 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Analysis
non-progression rate (objective response or stable disease)
Measured: end of Cycle 6 of study treatment (24 weeks)
Secondary outcomes (1)
Efficacy Analysis
time to progression and overall survival
Measured: were time to progressive disease, survival, duration of partial response, complete response and stable disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startJan 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellxpert Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Responsible party
- Sponsor
- Investigators
- S. G. Eckhardt, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073892
- Sponsor's protocol ID
- PROGEN-PR88201
- Other IDs
- CDR0000335412, COMIRB-01-207
- Status last verified
- Jun 2022
- First submitted
- 10 Dec 2003
- Last updated
- 27 Jun 2022
- Results posted
- No
- Individual data sharing
- Undecided
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
- NCT00073892
- Acronym / sponsor ID
- PROGEN-PR88201
- Keywords
- unspecified adult solid tumor, protocol specific, stage IV melanoma, recurrent melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cellxpert Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Study start
- Jan 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 11 Dec 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.
RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PI-88 | Experimental | Drug: PI-88Patients receive four consecutive days treatment each week in a 4-week cycle. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (40 listed)
- 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.
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-88Also: Mannopentaose phosphate sulfate250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle | Drug | PI-88 |
Primary outcome
Efficacy Analysis
Time frame: end of Cycle 6 of study treatment (24 weeks)
non-progression rate (objective response or stable disease)
1 secondary outcome
Efficacy Analysis
Time frame: were time to progressive disease, survival, duration of partial response, complete response and stable disease
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.
- Individual participant dataSharing planned: Undecided
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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.
S. G. Eckhardt, MD principal investigator
University of Colorado, Denver
5 sites in 2 countries: 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 (Skin) and Unspecified Adult Solid Tumor, Protocol Specific, run by Cellxpert Biotechnology Corp. at 5 sites in 2 countries.
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 14 inclusion and 40 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 5 sites in Australia, 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?
Efficacy Analysis (time frame: end of Cycle 6 of study treatment (24 weeks)). 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.