Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Eastern Cooperative Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00700882
First received: June 18, 2008
Last updated: February 7, 2014
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: dasatinib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Dasatinib in Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Objective tumor response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response duration [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Safety profile [ Designated as safety issue: Yes ]

Estimated Enrollment: 87
Study Start Date: May 2009
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed melanoma of 1 of the following subtypes:

    • Acral melanoma (defined as occurring on the palms, soles, or subungual sites)
    • Melanoma arising from the vagina and/or vulva
    • Melanoma arising on other mucosal surface (not vagina or vulva)
  • Unresectable locally advanced or metastatic disease
  • c-KIT mutation identified by polymerase chain reaction (PCR) and sequencing meeting 1 of the following criteria:

    • At least 1 mutation in exon 9, 11, 13, 17, or 18
    • At least 1 mutation in an exon not listed above
  • Metastatic tumor blocks are required for the evaluation of KIT mutations or amplifications
  • Measurable disease, defined as at least one measurable lesion by RECIST criteria

    • Prior radiotherapy to a measurable lesion allowed provided there is radiographic evidence of progression of that lesion
  • No ocular melanoma
  • Baseline bone scan required for patients with known bone metastases, elevated alkaline phosphatase, or symptoms raising suspicion of bone metastases
  • History or clinical evidence of brain metastasis allowed provided the following criteria are met:

    • Completed radiotherapy or surgical treatment of brain lesions AND there is no evidence of CNS progression for ≥ 8 weeks
    • Must not require corticosteroids for treatment of cerebral edema from brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC ≥ 3,000/mm³
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min
  • Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert disease)
  • AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
  • Serum potassium and magnesium normal (repletion allowed)
  • Total serum calcium or ionized calcium normal
  • INR ≤ 1.5 and PTT normal

    • Therapeutic anticoagulation with warfarin allowed provided INR ≤ 1.5 or PTT normal prior to initiating anticoagulation therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of bleeding diathesis
  • No other malignancies except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or other malignancies from which the patient has been continuously disease-free for ≥ 5 years
  • Patients must not have any clinically significant cardiovascular disease including the following:

    • Myocardial infarction or ventricular tachyarrhythmia within 6 months
    • Prolonged QTc >480 msec (Fridericia correction)
    • Ejection fraction less than institutional normal
    • Major conduction abnormality (unless a cardiac pacemaker is present)
    • Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) are to be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation
    • Patients with underlying cardiopulmonary dysfunction are excluded from the study
  • No uncontrolled hypertension, defined as systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg

    • Hypertension that is adequately controlled with medication allowed
  • No QTc prolongation, defined as a QTc interval ≥ 450 msecs
  • No concurrent serious illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics
  • No psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • No prior treatment with targeted therapies directed to C-KIT/PDGFR (e.g., imatinib mesylate or sunitinib malate)
  • Prior limb perfusion allowed
  • Prior systemic therapy allowed
  • At least 4 weeks since prior chemotherapy or immunotherapy

    • Prior adjuvant or neoadjuvant chemotherapy or immunotherapy allowed
  • At least 4 weeks since prior radiotherapy
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (i.e., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John wort)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700882

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni    501-686-8274      
United States, California
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center    650-498-7061    cctoffice@stanford.edu   
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi    954-776-3239      
Baptist Cancer Institute - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil    904-202-7051      
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center    561-745-5768      
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, MD    305-535-3310      
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute    404-778-1900      
United States, Hawaii
Oncare Hawaii, Incorporated - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kapiolani Medical Center at Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Straub Clinic and Hospital, Incorporated Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Queen's Cancer Institute at Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kuakini Medical Center Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii, Incorporated - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii, Incorporated - Lusitana Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii    808-586-2979      
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Elmhurst Memorial Hospital Recruiting
Elmhurst, Illinois, United States, 60126
Contact: Lucio Di Nunno, MD    806-725-8000      
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    563-359-9876      
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    563-359-9876      
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center    317-274-2552      
Veterans Affairs Medical Center - Indianapolis Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Theodore F. Logan, MD    317-278-7576      
William N. Wishard Memorial Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Theodore F. Logan, MD    317-278-7576      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Costas L. Constantinou, MD    563-359-9876      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Luke's Hospital - South Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur, MD    913-948-5588      
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Kansas City Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rakesh Gaur, MD    913-948-5588      
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Maryland
Greater Baltimore Medical Center Cancer Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Clinical Trials Office - Greater Baltimore Medical Center Canc    443-849-3706      
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce    410-955-8804    jhcccro@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital    877-726-5130      
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive    800-865-1125      
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    313-576-9363      
Green Bay Oncology, Limited - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Gerald K. Bayer, MD    920-432-6049      
Dickinson County Healthcare System Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Gerald K. Bayer, MD    920-432-6049      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD    269-373-7458      
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD    269-373-7458      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn, MD    612-884-6300      
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn, MD    612-884-6300      
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn, MD    612-884-6300      
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Patrick J. Flynn, MD    612-884-6300      
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD    612-884-6300      
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD    612-884-6300      
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn    612-873-5911      
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute    612-863-5654      
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Patrick J. Flynn, MD    612-884-6300      
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor    763-520-1893      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD    612-884-6300      
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD    612-884-6300      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD    612-884-6300      
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn, MD    612-884-6300      
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center    651-254-1517      
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Patrick J. Flynn, MD    612-884-6300      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn, MD    612-884-6300      
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Patrick J. Flynn, MD    612-884-6300      
Minnesota Oncology - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn, MD    612-884-6300      
United States, Missouri
Heartland Hematology Oncology Associates, Incorporated Recruiting
Kansas City, Missouri, United States, 64118
Contact: Rakesh Gaur, MD    913-948-5588      
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD    913-948-5588      
North Kansas City Hospital Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Luke's Cancer Institute at Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur, MD    913-948-5588      
Parvin Radiation Oncology Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur, MD    913-948-5588      
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Joseph Oncology, Incorporated Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Rakesh Gaur, MD    913-948-5588      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla    417-269-4520      
St. John's Regional Health Center Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert L. Carolla    417-820-2000      
United States, Montana
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana    406-238-6962      
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick    406-329-7029      
United States, North Dakota
Medcenter One Hospital Cancer Care Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Edward J. Wos, DO    701-323-5741      
Mid Dakota Clinic, PC Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Clinical Trials Office - Mid Dakota Clinic, PC    701-530-6950      
St. Alexius Medical Center Cancer Center Recruiting
Bismarck, North Dakota, United States, 58502
Contact: Clinical Trials Office - St. Alexius Medical Center Cancer Cen    701-530-6950      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Jennifer E. Payne    330-745-1611      
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook, MD, FACS    216-778-4795      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center    419-226-9617      
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Joseph P. Lynch, MD    918-494-8275      
United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Clinical Trials Office - Bryn Mawr Hospital    610-645-2680      
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: Joseph Drabick, MD, FACP    717-531-8678      
Cancer Center of Paoli Memorial Hospital Recruiting
Paoli, Pennsylvania, United States, 19301-1792
Contact: Clinical Trials Office - Cancer Center of Paoli Memorial Hospi    610-648-1637      
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers    412-647-8073      
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: Joseph Drabick, MD, FACP    717-531-8678      
CCOP - Main Line Health Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman, MD    610-645-2000      
Lankenau Cancer Center at Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman, MD    610-645-2000      
United States, Wisconsin
Marshfield Clinic - Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Seth O. Fagbemi, MD    715-387-5426      
Marshfield Clinic Cancer Care at Regional Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Seth O. Fagbemi, MD    715-387-5426      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gerald K. Bayer, MD    920-432-6049      
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gerald K. Bayer, MD    920-432-6049      
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Gerald K. Bayer, MD    920-432-6049      
UW Cancer Center Johnson Creek Recruiting
Johnson Creek, Wisconsin, United States, 53038
Contact: Mark R. Albertini, MD    608-263-0117      
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Holy Family Memorial Medical Center Cancer Care Center Recruiting
Manitowoc, Wisconsin, United States, 54221-1450
Contact: Clinical Trials Office - Holy Family Memorial Medical Center C    920-320-2749      
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gerald K. Bayer, MD    920-432-6049      
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext 94457      
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Seth O. Fagbemi, MD    715-387-5426      
D.N. Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Michael A. Thompson    262-363-1901      
Regional Cancer Center at Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc    262-928-7878      
Green Bay Oncology, Limited - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Gerald K. Bayer, MD    920-432-6049      
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Seth O. Fagbemi, MD    715-387-5426      
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Seth O. Fagbemi, MD    715-387-5426      
St. Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Gerald K. Bayer, MD    920-432-6049      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Seth O. Fagbemi, MD    715-387-5426      
Green Bay Oncology, Limited - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Gerald K. Bayer, MD    920-432-6049      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
Marshfield Clinic - Wausau Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Seth O. Fagbemi, MD    715-387-5426      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Seth O. Fagbemi, MD    715-387-5426      
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Seth O. Fagbemi, MD    715-387-5426      
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Donald P. Lawrence, MD Massachusetts General Hospital
Principal Investigator: Kevin Kalinsky, MD Tufts Medical Center Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00700882     History of Changes
Other Study ID Numbers: CDR0000598300, E2607
Study First Received: June 18, 2008
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
stage IV melanoma
acral lentiginous malignant melanoma
mucosal melanoma
recurrent melanoma
stage IIIA melanoma
stage IIIB melanoma
stage IIIC melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014