Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

• ClinicalTrials.gov Identifier: NCT00003802
• Recruitment Status: Completed
• First Posted: May 2, 2003
• Last Update Posted: December 17, 2012
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information

• First Submitted Date: November 1, 1999
• First Posted Date: May 2, 2003
• Last Update Posted Date: December 17, 2012
• Study Start Date: February 1999
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma
• Official Title: A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Primary Purpose: Treatment

Condition

• Intraocular Melanoma
• Melanoma (Skin)

• Intervention: Drug: pyrazoloacridine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2002
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00003802
• Other Study ID Numbers: JHOC-J9875, CDR0000066946; U01CA063437 ( U.S. NIH Grant/Contract ); P30CA006973 ( U.S. NIH Grant/Contract ); JHOC-98111005; JHOC-JH9875; JHOC-T96-0116; NCI-T96-0116
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Study Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: William H. Sharfman, MD; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• PRS Account: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Verification Date: December 2012