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Clinical Trial of Sutent to Treat Metastatic Melanoma

Primary Purpose

Metastatic Melanoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sutent (sunitinib)

About this trial

This is an interventional treatment trial for Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed advanced stage III or IV melanoma with primary origin in mucosal, acral-lentiginous, or chronic sun-damaged skin. Advanced disease is defined as locally recurrent disease or metastatic disease not amenable to surgical therapy. Patients may enter tumor-testing phase even if they do not have recurrent disease.
Aberration of the KIT gene or KIT receptor on in-vitro testing of their tumor tissue.
Evidence of measurable disease by RECIST criteria [Appendix 2]. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1.
Adequate organ function
ECOG performance status 0 or 1.

Exclusion Criteria:

Major surgery or radiation therapy within 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
Diagnosis of any second malignancy within the last 2 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer, or in situ cervical cancer.
Active brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis on screening CT or MRI scan. Patients who have had central nervous system metastases treated by surgery or radiation therapy and with those CNS metastases considered in control will be eligible, provided measurable disease outside the CNS is present.
Any of the following within the 2 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
Prolonged QTc interval on baseline EKG (>450 msec for males or >470 msec for females)
Uncontrolled hypertension (> 160/100 mm hg despite optimal medical therapy).
Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g., QOL, are allowed.
Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg po daily for thromboprophylaxis is allowed).
Pregnant or breastfeeding.
Life expectancy less than 3 months.

Sites / Locations

California Pacific Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suntinib

Arm Description

Suntinib

Outcomes

Primary Outcome Measures

Determine the objective response rate of metastatic melanoma patients with KIT aberrations to therapy with sunitinib.

Secondary Outcome Measures

Study the safety and toxicity of sunitinib when given to metastatic melanoma patients with KIT aberrations.

Full Information

NCT ID

NCT00631618

First Posted

March 3, 2008

Last Updated

February 22, 2014

Sponsor

California Pacific Medical Center Research Institute

Collaborators

Pfizer, University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00631618

Brief Title

Clinical Trial of Sutent to Treat Metastatic Melanoma

Official Title

A Phase II Trial of Sutent in Metastatic Melanoma Patients With KIT Aberrations.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

California Pacific Medical Center Research Institute

Collaborators

Pfizer, University of California, San Francisco

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations. KIT is a gene that "codes for" (contains the genetic code that the body uses to make) a protein on the surface of cells in your body that is important in cell growth and cell division. The KIT protein seems to play a role in abnormal cell growth seen in acute leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas. Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and chronically sun damaged skin have recently been found to frequently contain mutations or increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has been found to contain abnormalities in the KIT gene. Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib malate works in these patients because of its activity against the KIT protein. The FDA also approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its effectiveness is probably due to its ability to block a different set of proteins. Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suntinib

Arm Type

Experimental

Arm Description

Suntinib

Intervention Type

Drug

Intervention Name(s)

Sutent (sunitinib)

Other Intervention Name(s)

sunitinib malate

Intervention Description

The initial dose will be 50mg daily taken for 4 consecutive weeks followed by 2-weeks off to comprise a complete cycle of 6 weeks.

Primary Outcome Measure Information:

Title

Determine the objective response rate of metastatic melanoma patients with KIT aberrations to therapy with sunitinib.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Study the safety and toxicity of sunitinib when given to metastatic melanoma patients with KIT aberrations.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed advanced stage III or IV melanoma with primary origin in mucosal, acral-lentiginous, or chronic sun-damaged skin. Advanced disease is defined as locally recurrent disease or metastatic disease not amenable to surgical therapy. Patients may enter tumor-testing phase even if they do not have recurrent disease. Aberration of the KIT gene or KIT receptor on in-vitro testing of their tumor tissue. Evidence of measurable disease by RECIST criteria [Appendix 2]. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable. Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1. Adequate organ function ECOG performance status 0 or 1. Exclusion Criteria: Major surgery or radiation therapy within 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated. NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment. Diagnosis of any second malignancy within the last 2 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer, or in situ cervical cancer. Active brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis on screening CT or MRI scan. Patients who have had central nervous system metastases treated by surgery or radiation therapy and with those CNS metastases considered in control will be eligible, provided measurable disease outside the CNS is present. Any of the following within the 2 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2. Prolonged QTc interval on baseline EKG (>450 msec for males or >470 msec for females) Uncontrolled hypertension (> 160/100 mm hg despite optimal medical therapy). Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g., QOL, are allowed. Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg po daily for thromboprophylaxis is allowed). Pregnant or breastfeeding. Life expectancy less than 3 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David R Minor, MD

Organizational Affiliation

California Pacific Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

California Pacific Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22261812

Citation

Minor DR, Kashani-Sabet M, Garrido M, O'Day SJ, Hamid O, Bastian BC. Sunitinib therapy for melanoma patients with KIT mutations. Clin Cancer Res. 2012 Mar 1;18(5):1457-63. doi: 10.1158/1078-0432.CCR-11-1987. Epub 2012 Jan 18.

Results Reference

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Clinical Trial of Sutent to Treat Metastatic Melanoma

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