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SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
F. Stephen Hodi, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

Clinical Details

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

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

Primary outcome:

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

To determine the time to progression of this patient population to treatment with SU011248

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Washington University in St. Louis, St. Louis, Missouri, United States

Vanderbilt University, Nashville, Tennessee, United States

Additional Information

Starting date: August 2007
Last updated: February 24, 2014

Page last updated: August 23, 2015

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