Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin); Intraocular Melanoma

Treatments: Drug: pyrazoloacridine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003802

JHOC-J9875, CDR0000066946

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-T96-0116

JHOC-JH9875

U01CA063437 (U.S. NIH Grant/Contract)

NCI-T96-0116

JHOC-98111005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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