A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)
- 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
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
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
S. G. Eckhardt, MD
University of Colorado, Denver
United States: Federal Government
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|