Malignant MelanomaPhase 2NCT00104884
FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
A Phase 2 study testing Depsipeptide in people with Malignant Melanoma and Melanoma, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Melanoma
- What is being tested?
- Depsipeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2005to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III unresectable or American Joint Committee on Cancer (AJCC) stage IV cutaneous, mucosal, ocular, or unknown primary melanoma with measurable disease by physical examination or imaging studies.
- Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy if the patient agrees.
- Normal electrocardiogram (EKG)
- Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA)
- Corrected QT (QTc) < 500 msec
- Age greater than or equal to 18
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- Negative pregnancy test
- Fertile patients must use effective contraception
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Normal organ and marrow function
- Patients on hydrochorthiazide should be switched to a potassium-sparing diuretic or another antihypertensive
- At least 4 weeks since prior radiotherapy
- Patients with cardiac hypertrophy may be enrolled but should be carefully monitored.
Who cannot join
- Prior FR901228 (depsipeptide)
- Prior chemotherapy
- Other concurrent chemotherapy
- Active central nervous system (CNS) metastases by brain computed tomography (CT) scan or magnetic resonance imaging (MRI)
- History of coronary atherosclerotic heart disease
- History of myocardial infarction
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- History of congestive heart failure
- Non-melanoma malignancy within the past 5 years except carcinoma in situ or squamous cell or basal cell skin cancer
- Pregnant or nursing women
- Conditions that in the opinion of the investigator would interfere with the ability of the patient to complete this protocol
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Depsipeptide
- Co-medication with an agent that causes QTc prolongation
- Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Concurrent radiotherapy
- Left ventricular hypertrophy (LVH) on their baseline EKG tracing
About this study
Official title: Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide).
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18 months.
- Conditions
- Malignant Melanoma, Melanoma
- Being tested
- Depsipeptide
- Keywords
- stage III melanoma, stage IV melanoma, Depsipeptide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepsipeptideDrug
Also called FR901228, FK228
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Depsipeptide | Experimental | Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression. Receives: Drug: Depsipeptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Response to Depsipeptide
Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR).
Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Measured: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study start4 Oct 2005
- Primary completionMay 2006
- Study completionMar 2009
Why it stopped: The study was terminated on May 17, 2006 due to slow accrual.
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.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David H. Lawson, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104884
- Sponsor's protocol ID
- CDR0000415355
- Other IDs
- U10CA021115, E1603
- Status last verified
- Jun 2023
- First submitted
- 3 Mar 2005
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00104884
- Acronym / sponsor ID
- CDR0000415355
- Conditions
- Malignant Melanoma, Melanoma
- Keywords
- stage III melanoma, stage IV melanoma, Depsipeptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on May 17, 2006 due to slow accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Oct 2005 (actual)
- Primary completion
- May 2006 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Mar 2005 (estimated)
- Results
- Posted 2 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide).
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depsipeptide | Experimental | Drug: DepsipeptideDepsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Stage III unresectable or American Joint Committee on Cancer (AJCC) stage IV cutaneous, mucosal, ocular, or unknown primary melanoma with measurable disease by physical examination or imaging studies.
- Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy if the patient agrees.
- Normal electrocardiogram (EKG)
- Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA)
- Corrected QT (QTc) < 500 msec
Key exclusion criteria (16 listed)
- Prior FR901228 (depsipeptide)
- Prior chemotherapy
- Other concurrent chemotherapy
- Active central nervous system (CNS) metastases by brain computed tomography (CT) scan or magnetic resonance imaging (MRI)
- History of coronary atherosclerotic heart disease
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 |
|---|---|---|
| DepsipeptideAlso: FR901228, FK228Given IV | Drug | Depsipeptide |
Primary outcome
Proportion of Patients With Response to Depsipeptide
Time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years
Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR). Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David H. Lawson, MD study chair
Emory University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Depsipeptide in people with Malignant Melanoma and Melanoma, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. 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: stopped early, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 Mar 2016). 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?
Proportion of Patients With Response to Depsipeptide (time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2023.