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

Phase 1

Completed

• Conditions: Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: PI-88

• Registration Number: NCT00073892
• Lead Sponsor: Cellxpert Biotechnology Corp.

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 Timeline

• Study First Submitted: 2003-12-10
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Study Start: 2004-01
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PI-88	PI-88	Patients receive four consecutive days treatment each week in a 4-week cycle.

Primary Outcome Measures

Name	Time	Method
Efficacy Analysis	end of Cycle 6 of study treatment (24 weeks)	non-progression rate (objective response or stable disease)

Secondary Outcome Measures

Name	Time	Method
Efficacy Analysis	were time to progressive disease, survival, duration of partial response, complete response and stable disease	time to progression and overall survival

Trial Locations

Locations (5)

Queen Elizabeth Hospital; 🇦🇺 Woodville, South Australia, Australia

Sir Charles Gairdner Hospital - Perth; 🇦🇺 Perth, Western Australia, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia