Melanoma (Skin)Phase 2NCT00450372
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
A Phase 2 study testing ADI-PEG-20 and Pharmacology Studies in people with Melanoma (Skin), run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- ADI-PEG-20 and Pharmacology Studies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
About this study
Official title: Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
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.
Read the 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)
- Being tested
- ADI-PEG-20, Pharmacology Studies
- Keywords
- recurrent melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG-20Biological
Also called Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)
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 StudiesOther
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
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 | Experimental | Not described Receives: Biological: ADI-PEG-20; Other: Pharmacology Studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 16 months
Secondary outcomes (2)
Median Overall Survival
Overall survival will be estimated using the product-limit method of Kaplan \& Meier.
Measured: Up to 16 months
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
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startJun 2004
- Primary completionJan 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn G. Feun, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450372
- Sponsor's protocol ID
- 20030698
- Other IDs
- SCCC-2003045
- Status last verified
- Dec 2016
- First submitted
- 20 Mar 2007
- Last updated
- 8 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22472884
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00450372
- Acronym / sponsor ID
- 20030698
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 1 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 | Experimental | Biological: ADI-PEG-20, Other: Pharmacology Studies |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-PEG-20Also: Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)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. | Biological | ADI-PEG 20 |
| Pharmacology Studiestissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue | Other | ADI-PEG 20 |
Primary outcome
Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.
Time frame: Up to 16 months
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
2 secondary outcomes
Median Overall Survival
Time frame: Up to 16 months
Median Time to Progression
Time frame: Up to 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22472884Feun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn G. Feun, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADI-PEG-20 and Pharmacology Studies in people with Melanoma (Skin), run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor. (time frame: Up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00450372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.