PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)|
- Efficacy Analysis [ Time Frame: end of Cycle 6 of study treatment (24 weeks) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]time to progression and overall survival
|Study Start Date:||January 2004|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|