Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-26 @ 8:58 PM
Study NCT ID:
NCT00073892
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2003-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
Sponsor:
Cellxpert Biotechnology Corp.
Organization:
Study Overview
Official Title:
A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: