Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery

NCT00450372 | Completed Phase 2 Results DMC

• 2 other identifiers: 20030698SCCC-2003045
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.

  Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD

  Up to 16 months

Secondary Outcomes (2)

• Median Overall Survival

  Up to 16 months

• Median Time to Progression

  Up to 16 months

Study Arms (1)

ADI-PEG 20

EXPERIMENTAL

Biological: ADI-PEG-20; Other: Pharmacology Studies

Interventions

ADI-PEG-20 BIOLOGICAL

There will be 6 cycles planned, each consisting of 4 weeks. During each cycle subjects will receive injections on days 1, 8, 15, and 22 + 2 days. All subjects may begin treatment with 160 IU/m2 on a weekly basis.

Also known as: Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)

ADI-PEG 20

Pharmacology Studies OTHER

tissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue

ADI-PEG 20

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Feun LG, Marini A, Walker G, Elgart G, Moffat F, Rodgers SE, Wu CJ, You M, Wangpaichitr M, Kuo MT, Sisson W, Jungbluth AA, Bomalaski J, Savaraj N. Negative argininosuccinate synthetase expression in melanoma tumours may predict clinical benefit from arginine-depleting therapy with pegylated arginine deiminase. Br J Cancer. 2012 Apr 24;106(9):1481-5. doi: 10.1038/bjc.2012.106.

  PMID: 22472884 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

ADI PEG20; arginine deiminase; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.

Results Point of Contact

• Title: Lynn Feun MD
• Organization: UM/Sylvester Comprehensive Cancer Center

lfeun@med.miami.edu

305-243-4909

Study Officials

• Lynn G. Feun, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: June 1, 2004
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 8, 2017
• Results First Posted: May 1, 2013

Record last verified: 2016-12

Locations

US (1)