Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003802

Enrollment

Unknown

Registered

2003-05-02

Start date

1999-02-28

Completion date

2002-10-31

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Melanoma, Melanoma (Skin)

Keywords

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

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.

Interventions

DRUGpyrazoloacridine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026