SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Acral Lentiginous Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00577382
• Other study ID #: 06-145
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: June 8, 2016
• Start date: August 2007
• Est. completion date: July 2016

Study information

• Verified date: June 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how effective SU011248 works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. SU011248 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.

Description:

• Participants will be given a bottle of SU011248 pills and will be asked to take pills once daily for 28 days on an ongoing basis. Participants will return every 28 days for new pills.

• During all treatment cycles, participants will have a physical exam and undergo blood tests at every visit.

• After a month of receiving the study drug participants will undergo a repeat PET scan to see if the drug has caused any early changes to their cancer.

• At week 8 a repeat chest, abdomen and pelvic CT will be performed.

• Participants will be on this research study for approximately one year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: July 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acral Lentiginous Malignant Melanoma
• Melanoma
• Mucosal Lentiginous Melanoma

Intervention

Drug:
• Sunitinib
Oral pill taken daily for 4 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Vanderbilt University	Nashville	Tennessee
United States	Washington University in St. Louis	St. Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate of this patient population to treatment with SU011248		2 years	No
Primary	To determine the time to progression of this patient population to treatment with SU011248		Years	No