NCT00073892

PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma

A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Cellxpert Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Melanoma (Skin)
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	PI-88	250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2003-12-11
• Last updated: 2022-06-27

Locations

5 sites across 2 countries: United States, Australia