Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003802
• Other study ID #: JHOC-J9875, CDR0000066946
• Secondary ID: U01CA063437P30CA
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 12, 2012
• Start date: February 1999
• Est. completion date: October 2002

Study information

• Verified date: December 2012
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

Intervention

Drug:
• pyrazoloacridine

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,