Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
- Registration Number
- NCT00700882
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.
- Detailed Description
OBJECTIVES:
Primary
* To estimate the objective tumor response rate in patients with KIT-positive, unresectable, locally advanced or metastatic acral or mucosal melanoma treated with dasatinib monotherapy.
Secondary
* To estimate the response duration in patients treated with this drug.
* To estimate the progression-free survival of patients treated with this drug.
* To evaluate the safety profile of this drug in these patients.
* To evaluate the PDGFR expression and activation of Src family kinases in tumor samples and correlate these parameters with response to treatment.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tissue samples may be collected from some patients for correlative studies.
After completion of study therapy, patients are followed up periodically for up to 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dasatinib dasatinib Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Objective Response Rate Among KIT-positive Patients Every 6 weeks; up to 5 years Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
- Secondary Outcome Measures
Name Time Method Duration of Response for Dasatinib Monotherapy in This Patient Population Every 6 weeks; up to 5 years Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Progression-free Survival Every 6 weeks; up to 5 years Progression-free survival is defined as the time from registration to development of progressive disease. Patients without documented progressive disease are censored at the date of last disease assessment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Trial Locations
- Locations (151)
Stanford Cancer Center
🇺🇸Stanford, California, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Elmhurst Memorial Hospital
🇺🇸Elmhurst, Illinois, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Greater Baltimore Medical Center Cancer Center
🇺🇸Baltimore, Maryland, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Parvin Radiation Oncology
🇺🇸Liberty, Missouri, United States
Minnesota Oncology - Woodbury
🇺🇸Woodbury, Minnesota, United States
Lewistown Hospital
🇺🇸Lewistown, Pennsylvania, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
D.N. Greenwald Center
🇺🇸Mukwonago, Wisconsin, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis
🇺🇸Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital
🇺🇸Indianapolis, Indiana, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Saint Joseph Oncology, Incorporated
🇺🇸Saint Joseph, Missouri, United States
Barberton Citizens Hospital
🇺🇸Barberton, Ohio, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
🇺🇸Oconomowoc, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
St. Nicholas Hospital
🇺🇸Sheboygan, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Kapiolani Medical Center at Pali Momi
🇺🇸'Aiea, Hawaii, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Kuakini Medical Center
🇺🇸Honolulu, Hawaii, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Oncare Hawaii, Incorporated - Pali Momi
🇺🇸'Aiea, Hawaii, United States
Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Castle Medical Center
🇺🇸Kailua, Hawaii, United States
Cancer Center of Kansas, PA - McPherson
🇺🇸McPherson, Kansas, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Minnesota Oncology - Maplewood
🇺🇸Maplewood, Minnesota, United States
New Ulm Medical Center
🇺🇸New Ulm, Minnesota, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Saint Luke's Hospital - South
🇺🇸Overland Park, Kansas, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
CCOP - Kansas City
🇺🇸Prairie Village, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Marshfield Clinic - Chippewa Center
🇺🇸Chippewa Falls, Wisconsin, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Marshfield Clinic - Lakeland Center
🇺🇸Minocqua, Wisconsin, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
UW Cancer Center Johnson Creek
🇺🇸Johnson Creek, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
🇺🇸Rhinelander, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center
🇺🇸Manitowoc, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
Marshfield Clinic - Wausau Center
🇺🇸Wausau, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Heartland Hematology Oncology Associates, Incorporated
🇺🇸Kansas City, Missouri, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States