Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

Phase 2

Completed

• Conditions: Intraocular Melanoma; Melanoma (Skin)

• Registration Number: NCT00003802
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.

Detailed Description

OBJECTIVES:

* Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma.

* Determine the toxic effects of PZA in this patient population.

* Determine the pharmacokinetic profile of PZA in these patients.

OUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.

Patients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 28-70 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 1999-11-01
• Study Completion: 2002-10
• Study First Submitted QC: 2003-05-01
• Study First Posted: 2003-05-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States