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

NCT ID: NCT00450372

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2012-02-29

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.

Detailed Description

OBJECTIVES:

Primary:

• Determine the clinical response (complete and partial response) in patients with unresectable metastatic melanoma treated with pegylated arginine deiminase.

Secondary:

• Determine the toxicity profile of this drug in these patients.
• Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
• Determine the progression-free survival and overall survival of patients treated with this drug.

OUTLINE: Patients receive pegylated arginine deiminase intramuscularly once or twice a week in weeks 1-4. Courses repeat every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are acquired at baseline and every 2 weeks thereafter for pharmacokinetic and pharmacodynamic studies.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 5 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADI-PEG 20

Group Type: EXPERIMENTAL

ADI-PEG-20

Intervention Type: 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.

Pharmacology Studies

Intervention Type: 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

Interventions

ADI-PEG-20

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.

Intervention Type: BIOLOGICAL

Pharmacology Studies

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

Intervention Type: OTHER

Other Intervention Names

Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)

Eligibility Criteria

Inclusion 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 < 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn G. Feun, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22472884 (View on PubMed)

Other Identifiers

SCCC-2003045

Identifier Type: -

Identifier Source: secondary_id

20030698

Identifier Type: -

Identifier Source: org_study_id