A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
PRIMARY OBJECTIVES:
I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated
with dinaciclib.
SECONDARY OBJECTIVES:
I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate
the response rate (confirmed and unconfirmed complete and partial responses) in the subset
of patients with measurable disease.
III. To assess the safety and tolerability of dinaciclib given to patients with stage IV
melanoma.
OUTLINE: This is a multicenter study.
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 3
years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
1 year
No
Christopher Lao
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-01935
NCT00937937
July 2009
Name | Location |
---|---|
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
Loyola University Medical Center | Maywood, Illinois 60153 |
South Georgia Medical Center | Valdosta, Georgia 31603 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Boston Medical Center | Boston, Massachusetts 02118 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Salina Regional Health Center | Salina, Kansas 67401 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Grandview Hospital | Dayton, Ohio 45405 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Highland General Hospital | Oakland, California 94602 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Wayne Hospital | Greenville, Ohio 45331 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Memorial Medical Center | Springfield, Illinois 62781 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
El Camino Hospital | Mountain View, California 94040 |
Wayne State University | Detroit, Michigan 48202 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Boca Raton Comprehensive Cancer Center | Boca Raton, Florida 33486 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hays Medical Center | Hays, Kansas 67601 |
Saint Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Saint Anthony's Health | Alton, Illinois 62002 |
Good Samaritan Regional Medical Center | Mt. Vernon, Illinois 62864 |
Hematology Oncology Consultants Limited | Naperville, Illinois 60540 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Stormont-Vail Regional Health Center | Topeka, Kansas 66604 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Medical Center of Louisiana | New Orleans, Louisiana 70112 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Greenville CCOP | Greenville, South Carolina 29615 |
Greenville Memorial Hospital | Greenville, South Carolina 29605 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Olathe Cancer Center | Olathe, Kansas 66061 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas-Greer Radiation Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas-Greer Medical Oncology | Greer, South Carolina 29650 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
Saint Charles Medical Center-Bend | Bend, Oregon 97701 |
Memorial Hospital Of Martinsville | Martinsville, Virginia 24115 |
Cancer Care Center of Decatur | Decatur, Illinois 62526 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Via Christi Hospital-Pittsburg | Pittsburg, Kansas 66762 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Promise Regional Medical Center-Hutchinson | Hutchinson, Kansas 65702 |
Saint Louis Cancer and Breast Institute-South City | Saint Louis, Missouri 63109 |
Nevada Cancer Institute-Summerlin Campus | Las Vegas, Nevada 89135 |
Self Regional Healthcare | Greenwood, South Carolina 29646 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |