Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
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.
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. ;
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