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

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ADI-PEG-20

Pharmacology Studies

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADI-PEG 20

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Median Overall Survival

Overall survival will be estimated using the product-limit method of Kaplan & Meier.

Median Time to Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Full Information

NCT ID

NCT00450372

First Posted

March 20, 2007

Last Updated

December 14, 2016

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00450372

Brief Title

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

Official Title

Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADI-PEG 20

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

ADI-PEG-20

Other Intervention Name(s)

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

Intervention Description

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

Other

Intervention Name(s)

Pharmacology Studies

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 16 months

Secondary Outcome Measure Information:

Title

Median Overall Survival

Description

Overall survival will be estimated using the product-limit method of Kaplan & Meier.

Time Frame

Up to 16 months

Title

Median Time to Progression

Description

Time Frame

Up to 16 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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 < 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lynn G. Feun, MD

Organizational Affiliation

University of Miami Sylvester Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami Sylvester Comprehensive Cancer Center - Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22472884

Citation

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.

Results Reference

result

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

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