Phase 2
N=38
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Melanoma (Skin)
Bottom Line
View on ClinicalTrials.gov: NCT00450372 ↗Enrolled (actual)
38
Serious AEs
24.3%
Results posted
May 2013
Primary outcome: Primary: Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor. — 0; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ADI-PEG-20 (Biological); Pharmacology Studies (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor. |
0; 4 | — |
| SECONDARY Median Overall Survival |
9.3; 14.6 | — |
| SECONDARY Median Time to Progression |
1.8; 3.6 | — |
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 deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.
Eligibility Criteria
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 60 mg/dL
- Amylase 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
Data sourced from ClinicalTrials.gov (NCT00450372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.