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A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William H. Sharfman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J9875, CDR0000066946

NCT ID:

NCT00003802

Start Date:

February 1999

Completion Date:

October 2002

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • 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
  • Melanoma
  • Uveal Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410