Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2002-10-31

Brief Summary

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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

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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.

Conditions

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Intraocular Melanoma Melanoma (Skin)

Keywords

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iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma stage IV melanoma recurrent melanoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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pyrazoloacridine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive
* Bidimensionally measurable disease
* No pleural effusions or ascites
* No untreated CNS metastases
* Stable brain metastases by CT or MRI scan

* At least 4 weeks since prior steroid therapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 4,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active infection
* No known hypersensitivity to E.coli derived proteins
* No other serious medical problems
* No more than 1 primary malignancy within past 5 years, other than:

* Nonmelanomatous skin cancer
* Carcinoma in situ of the cervix
* No history of spinal cord compression

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed
* No other prior radiotherapy

Surgery:

* At least 2 weeks since prior surgery and recovered

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William H. Sharfman, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States