Status:
COMPLETED
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Lead Sponsor:
University of Miami
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth. PURPOSE: This phase II trial is studying how well pegylated arginine de...
Detailed Description
OBJECTIVES: Primary: * Determine the clinical response (complete and partial response) in patients with unresectable metastatic melanoma treated with pegylated arginine deiminase. Secondary: * Det...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma, meeting any of the following criteria:
- Progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy
- No longer responding to standard therapy OR have refused standard therapy
- Unresectable disease
- Measurable or evaluable disease
- No clinical ascites
- No symptomatic pleural effusion
- PATIENT CHARACTERISTICS:
- Life expectancy ≥ 12 weeks
- Karnofsky performance status 70-100%
- Bilirubin ≤ 3.0 mg/dL
- Albumin ≥ 3.0 g/dL
- Alkaline phosphatase \< 5 times upper limit of normal (ULN)
- Serum glucose \> 60 mg/dL
- Amylase \< 1.5 times ULN
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- No New York Heart Association class III-IV heart failure
- No serious infection requiring treatment with antibiotics
- No known allergy to E. coli drug products (e.g., sargramostim \[GM-CSF\])
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior anticancer therapy
- At least 4 weeks since prior surgery and recovered
- No concurrent participation in another investigational drug study
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00450372
Start Date
June 1 2004
End Date
February 1 2012
Last Update
February 8 2017
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136