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

Phase 2
18 Years
Open (Enrolling)
Mucosal Melanoma, Acral/Lentiginous Melanoma

Thank you

Trial Information

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

- 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.

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

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To determine the response rate of this patient population to treatment with SU011248

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

January 2014

Related Keywords:

  • Mucosal Melanoma
  • Acral/Lentiginous Melanoma
  • Sutent
  • malignant melanoma
  • Melanoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Vanderbilt University Nashville, Tennessee  37232-6305
Washington University in St. Louis St. Louis, Missouri  63110