Adult Alveolar Soft-part SarcomaPhase 2NCT00112463
Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma
A Phase 2 study testing romidepsin in people with Adult Alveolar Soft-part Sarcoma and Adult Angiosarcoma, run by National Cancer Institute (NCI).
Trial summary
This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma
- What is being tested?
- romidepsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2005to 23 Oct 2008
- 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
- Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies:
- Gastrointestinal stromal tumors (GIST)
- Refractory to imatinib mesylate
- Desmoplastic small round cell tumors
- Clear cell sarcoma
- Extraskeletal osteosarcoma*
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- Extraskeletal Ewing's sarcoma*
- Extraskeletal (myxoid) chondrosarcoma*
- Secondary STS (e.g., radiation-induced STS or neurofibrosarcoma due to neurofibromatosis) allowed
- Metastatic or unresectable disease
- No standard curative therapy exists
- Patients with GIST must have received and progressed on imatinib mesylate
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No known brain metastases
- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- Performance status - Karnofsky 50-100%
- More than 3 months
- White blood cells (WBC) ⥠3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ⤠2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Creatinine < 1.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- QTc ≤ 480 msec
Who cannot join
- No cardiac abnormalities (e.g., congenital long QT syndrome)
- No myocardial infarction within the past year
- No history of coronary artery disease (e.g., angina Canadian Class II-IV or positive stress imaging study)
- No cardiac ischemia (ST depression >2 mm) by electrocardiogram (ECG)
- No New York Heart Association Class II-IV congestive heart failure
- Ejection fraction > 50% by multi gated acquisition scan (MUGA) scan or echocardiogram
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- No history of sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, or cardiac arrest unless controlled by an automatic implantable cardioverter defibrillator
- No hypertrophic or restrictive cardiomyopathy from prior treatment or other causes
- No significant left ventricular hypertrophy
- No uncontrolled hypertension (i.e., blood pressure ≥ 160/95 mm Hg)
- No cardiac arrhythmia requiring anti-arrhythmic medication
- Beta blocker or calcium channel blocker allowed
- Patients on digitalis that cannot be discontinued not allowed
- No Mobitz II second degree block without a pacemaker (first degree or Mobitz I second degree block, bradyarrhythmias, or sick sinus syndrome require Holter monitoring and evaluation by cardiology)
- No uncontrolled dysrhythmia
- No poorly controlled angina
- No other cardiac disease
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to FR901228
- No ongoing or active infection
- No iatrogenic immune deficiency or immune deficiency secondary to an underlying disorder
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Potassium ≥ 4.0 mmol/L
- Magnesium ≥ 2.0 mg/dL
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No concurrent anticancer biologic agents
- No more than 1 prior chemotherapy regimen for sarcoma
- Adjuvant chemotherapy preceding disease relapse is considered 1 prior chemotherapy regimen
- Patients with GIST may have received up to 3 prior chemotherapy regimens comprising imatinib mesylate and/or sunitinib malate provided no other chemotherapy agents were used
- No prior FR901228 (depsipeptide)
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No prior cumulative doxorubicin dose > 500 mg/m^2
- No other concurrent anticancer chemotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent anticancer radiotherapy
- At least 4 weeks since prior surgery
- No prior organ transplantation
- Recovered from all prior therapy
- No concurrent medications that cause QTc prolongation
- No concurrent combination highly active anti-retroviral therapy for HIV-positive patients
- No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate)
- No other concurrent investigational agents
- No other concurrent anticancer agents
About this study
Official title: A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas
This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the response rates of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.
II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.
III. To evaluate the scope and extent of acute toxicities associated with single-agent depsipeptide when given to patients with soft tissue sarcomas.
OUTLINE: This is a multicenter study.
Patients receive depsipeptide (romidepsin) 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. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
After completion of study treatment, patients are followed up every 2 months.
- Conditions
- Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma
- Being tested
- romidepsin
- Medical subject headings
- Sarcoma, Alveolar Soft Part, Hemangiosarcoma, Sarcoma, Chondrosarcoma, Extraskeletal Myxoid, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Histiocytoma, Malignant Fibrous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
romidepsinDrug
Also called FK228, FR901228, Istodax
DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (single-agent depsipeptide) | Experimental | Patients receive depsipeptide (romidepsin) 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. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. Receives: Drug: romidepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response (Complete and Partial)
Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR
Measured: While on treatment - max of 16 months
Time to Progression
Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.
Measured: Until disease progression - max of 48 months
Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study.
A summary of the individual toxicities can be found in the AE/SAE results.
Measured: During treatment (max of 16 months) and for 1 month following treatment
Secondary outcomes (1)
Survival
Months from first treatment until death or the last date of contact
Measured: Max of 98 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study start7 Jan 2005
- Primary completion23 Oct 2008
- Study completion23 Oct 2008
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 Adult Alveolar Soft-part SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul Savage, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112463
- Sponsor's protocol ID
- NCI-2012-01037
- Other IDs
- NCI-2012-01037, CCCWFU 71103, 6319, U10CA081851, P30CA012197
- Status last verified
- May 2017
- First submitted
- 2 Jun 2005
- Last updated
- 14 Jun 2017
- 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00112463
- Acronym / sponsor ID
- NCI-2012-01037
- Conditions
- Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Jan 2005 (actual)
- Primary completion
- 23 Oct 2008 (actual)
- Study completion
- 23 Oct 2008 (actual)
- First posted
- 3 Jun 2005 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the response rates of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.
II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.
III. To evaluate the scope and extent of acute toxicities associated with single-agent depsipeptide when given to patients with soft tissue sarcomas.
OUTLINE: This is a multicenter study.
Patients receive depsipeptide (romidepsin) 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. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
After completion of study treatment, patients are followed up every 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (single-agent depsipeptide) | Experimental | Drug: romidepsinPatients receive depsipeptide (romidepsin) 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. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies:
- Secondary STS (e.g., radiation-induced STS or neurofibrosarcoma due to neurofibromatosis) allowed
- Metastatic or unresectable disease
- No standard curative therapy exists
- Patients with GIST must have received and progressed on imatinib mesylate
Key exclusion criteria (45 listed)
- No cardiac abnormalities (e.g., congenital long QT syndrome)
- No myocardial infarction within the past year
- No history of coronary artery disease (e.g., angina Canadian Class II-IV or positive stress imaging study)
- No cardiac ischemia (ST depression >2 mm) by electrocardiogram (ECG)
- No New York Heart Association Class II-IV congestive heart failure
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 |
|---|---|---|
| romidepsinAlso: FK228, FR901228, IstodaxDEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting. | Drug | Treatment (single-agent depsipeptide) |
Primary outcome
Objective Tumor Response (Complete and Partial)
Time frame: While on treatment - max of 16 months
Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR
Time to Progression
Time frame: Until disease progression - max of 48 months
Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.
Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
Time frame: During treatment (max of 16 months) and for 1 month following treatment
The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study. A summary of the individual toxicities can be found in the AE/SAE results.
1 secondary outcome
Survival
Time frame: Max of 98 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Paul Savage principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing romidepsin in people with Adult Alveolar Soft-part Sarcoma and Adult Angiosarcoma, run by National Cancer Institute (NCI).
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 25 inclusion and 45 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: finished, as of the sponsor's last update on 14 Jun 2017. 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 12 May 2017). 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?
Objective Tumor Response (Complete and Partial) (time frame: While on treatment - max of 16 months). The study lists 3 primary outcomes in all. 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 14 Jun 2017.