Clinical trial NCT00003802: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: William H. Sharfman, MD
role: STUDY_CHAIR
References: