Mucosal Lentiginous MelanomaPhase 2NCT00577382

SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

A Phase 2 study testing Sunitinib in people with Mucosal Lentiginous Melanoma and Acral Lentiginous Malignant Melanoma, run by Dana-Farber Cancer Institute at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
What is being tested?: Sunitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 5 sitesUnited States
Study dates: Aug 2007to Aug 2014
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

History of primary mucosal or acral/lentiginous melanoma
Histologically documented stage III unresectable or IV metastatic melanoma
ECOG Performance Status 0,1 or 2
Estimated life expectancy of 6 months or greater
18 years of age or older
Lab values as outlined in protocol

Show all 9Show fewer

Tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing
Negative pregnancy test within 48 hours of starting treatment
At least one measurable site of disease as defined by at least 1cm in greatest dimension

Who cannot join

Severe and/or uncontrolled medical disease
Pregnant or nursing mothers
Known brain metastasis. History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in situ
Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval >450msec for males of >470 msec for females

Show all 17Show fewer

Hypertension that cannot be controlled by medication
Any of the following within 12 months prior to starting treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
Concurrent treatment with warfarin
Prior treatment with SU011248 or any other antiangiogenic agent
No H2 blockers or proton pump inhibitors
Known chronic liver disease
Known HIV infection
Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 4 weeks prior to study entry
Major surgery within 4 weeks prior to study entry
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Vanderbilt University
Nashville, Tennessee, 37212
Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.

Read the detailed description

OBJECTIVES:

Primary

To determine the proportion of participants with metastatic mucosal or acral/lentiginous melanoma who are alive and without disease progression at two months after beginning treatment with sunitinib.
To determine the best overall response rate.

Secondary

To determine the time to progression and overall survival.
To correlate c-kit mutational status with response to therapy.
To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.

Conditions: Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
Being tested: Sunitinib
Keywords: Sutent, malignant melanoma
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SunitinibDrug
Also called Sutent, SU011248

Study groups in NCT00577382
Study group	Role	What they receive
Sunitinib	Experimental	Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year. Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year. Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

2-month Progression-free Survival Rate
2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Measured: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.

Secondary outcomes (3)

Best Overall Response Rate
The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Measured: Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.
Overall Survival
Overall survival (OS) is defined as the time from study entry to death or date last known alive.
Measured: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).
Time to Progression
Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Measured: Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Aug 2014

First posted20 Dec 2007 (estimated)
Study startAug 2007
Primary completionAug 2014
Study completionAug 2014

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 Mucosal Lentiginous MelanomaStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe 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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00577382
Sponsor's protocol ID: 06-145
Status last verified: Jun 2016
First submitted: 18 Dec 2007
Last updated: 8 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Buchbinder EI, Sosman JA, Lawrence DP, McDermott DF, Ramaiya NH, Van den Abbeele AD, Linette GP, Giobbie-Hurder A, Hodi FS. Phase 2 study of sunitinib in patients with metastatic mucosal or acral melanoma. Cancer. 2015 Nov 15;121(22):4007-15. doi: 10.1002/cncr.29622. Epub 2015 Aug 11.
PubMed 26264378

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
Not yet recruitingPhase 2
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Advanced Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
Dinaciclib in Treating Patients With Stage IV Melanoma
Acral Lentiginous Melanoma, Cutaneous Nodular Melanoma

All Mucosal Lentiginous Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
ClinicalTrials.gov ID: NCT00577382
Acronym / sponsor ID: 06-145
Conditions: Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
Keywords: Sutent, malignant melanoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Pfizer
Study start: Aug 2007
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 20 Dec 2007 (estimated)
Results: Posted 8 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

To determine the proportion of participants with metastatic mucosal or acral/lentiginous melanoma who are alive and without disease progression at two months after beginning treatment with sunitinib.
To determine the best overall response rate.

Secondary

To determine the time to progression and overall survival.
To correlate c-kit mutational status with response to therapy.
To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sunitinib	Experimental	Drug: SunitinibCohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year. Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

History of primary mucosal or acral/lentiginous melanoma
Histologically documented stage III unresectable or IV metastatic melanoma
ECOG Performance Status 0,1 or 2
Estimated life expectancy of 6 months or greater
18 years of age or older

Key exclusion criteria (17 listed)

Severe and/or uncontrolled medical disease
Pregnant or nursing mothers
Known brain metastasis. History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in situ
Grade III/IV cardiac problems as defined by the New York Heart Association Criteria

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
SunitinibAlso: Sutent, SU011248	Drug	Sunitinib

Primary outcome

2-month Progression-free Survival Rate
Time frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.
2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

3 secondary outcomes

Best Overall Response Rate
Time frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.
Overall Survival
Time frame: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).
Time to Progression
Time frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).

Results and safety

Results posted to the registry on 8 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A-Sunitinib Intermittent Dosing	21	0
Cohort B-Sunitinib Continuous Dosing	31	0

Primary outcome: 2-month Progression-free Survival Rate

Time frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.. Number (95% Confidence Interval). Unit: proportion of patients

Measure	Cohort A-Sunitinib Intermittent Dosing n = 21	Cohort B-Sunitinib Continuous Dosing n = 31
Value	.52 (.30 to .74)	.52 (.33 to .70)

Population analysed: The analysis dataset is comprised of treated patients.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE assessment was ongoing from the start of study drug and up to day 30 post-treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A-Sunitinib Intermittent Dosing	10 of 21 (47.6%)	19 of 21 (90.5%)	Not reported
Cohort B-Sunitinib Continuous Dosing	13 of 31 (41.9%)	24 of 31 (77.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26264378Buchbinder EI, Sosman JA, Lawrence DP, McDermott DF, Ramaiya NH, Van den Abbeele AD, Linette GP, Giobbie-Hurder A, Hodi FS. Phase 2 study of sunitinib in patients with metastatic mucosal or acral melanoma. Cancer. 2015 Nov 15;121(22):4007-15. doi: 10.1002/cncr.29622. Epub 2015 Aug 11.
Individual participant dataSharing planned: No

Related trials for Mucosal Lentiginous Melanoma

Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
Not yet recruitingPhase 2
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Advanced Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
Dinaciclib in Treating Patients With Stage IV Melanoma
Acral Lentiginous Melanoma, Cutaneous Nodular Melanoma

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.

F. Stephen Hodi, MD principal investigator

Dana-Farber Cancer Institute

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Mucosal Lentiginous Melanoma and Acral Lentiginous Malignant Melanoma, run by Dana-Farber Cancer Institute at 5 sites 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?

The sponsor lists 9 inclusion and 17 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 8 Dec 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?

2-month Progression-free Survival Rate (time frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 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 NCT00577382, 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 Dec 2016.