Clinical Trial of Sutent to Treat Metastatic Melanoma

NCT00631618

Last updated date
Study Location
California Pacific Medical Center
San Francisco, California, 94115, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Metastatic MelanomaClinical Trial of Sutent to Treat Metastatic Melanoma
NCT00631618
  1. San Francisco, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Metastatic MelanomaTemozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma
NCT01005472
  1. Los Angeles, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical Trial of Sutent to Treat Metastatic Melanoma
Official Title  ICMJE A Phase II Trial of Sutent in Metastatic Melanoma Patients With KIT Aberrations.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE Drug: Sutent (sunitinib)
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.
Other Name: sunitinib malate
Study Arms  ICMJE Experimental: Suntinib
Suntinib
Intervention: Drug: Sutent (sunitinib)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)
12
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00631618
Other Study ID Numbers  ICMJE GA6181DN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Minor, MD, California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE
  • Pfizer
  • University of California, San Francisco
Investigators  ICMJE
Principal Investigator:David R Minor, MDCalifornia Pacific Medical Center
PRS Account California Pacific Medical Center Research Institute
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP