Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

NCT00003802 | Completed Phase 2

• 7 other identifiers: JHOC-J9875, CDR0000066946U01CA063437P30CA006973JHOC-98111005JHOC-JH9875JHOC-T96-0116NCI-T96-0116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Interventions

pyrazoloacridine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

NSC 366140

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• William H. Sharfman, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 2, 2003
• Study Start: February 1, 1999
• Study Completion: October 1, 2002
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)