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Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: November 1, 1999
Last updated: December 12, 2012
Last verified: December 2012

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.

Condition Intervention Phase
Intraocular Melanoma Melanoma (Skin) Drug: pyrazoloacridine Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Study Start Date: February 1999
Study Completion Date: October 2002
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


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


  • 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)


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


  • 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


Biologic therapy:

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


  • No prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • 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


  • At least 2 weeks since prior surgery and recovered
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003802

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: William H. Sharfman, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00003802     History of Changes
Other Study ID Numbers: JHOC-J9875, CDR0000066946
U01CA063437 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
Study First Received: November 1, 1999
Last Updated: December 12, 2012

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
NSC 366140
Antineoplastic Agents processed this record on July 27, 2017