Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT00073892
Brief 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.
Study:
NCT00073892
Study Brief:
Protocol Section:
NCT00073892