PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00073892|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : August 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific||Drug: PI-88||Phase 1 Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
Patients receive four consecutive days treatment each week in a 4-week cycle.
250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
Other Name: Mannopentaose phosphate sulfate
- Efficacy Analysis [ Time Frame: end of Cycle 6 of study treatment (24 weeks) ]non-progression rate (objective response or stable disease)
- Efficacy Analysis [ Time Frame: were time to progressive disease, survival, duration of partial response, complete response and stable disease ]time to progression and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073892
|United States, Colorado|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80010|
|Princess Alexandra Hospital|
|Brisbane, Queensland, Australia, 4102|
|Australia, South Australia|
|Queen Elizabeth Hospital|
|Woodville, South Australia, Australia, 5011|
|Melbourne, Victoria, Australia, 3004|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital - Perth|
|Perth, Western Australia, Australia, 6009|
|Principal Investigator:||S. G. Eckhardt, MD||University of Colorado, Denver|